A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

开始日期2026-01-20

申办/合作机构

National Cancer Institute

NCT06991920

/ Not yet recruitingN/AIIT

Immune-targeted Combination With Acute Lymphoblastic Leukemia-like Chemotherapy for Adult of Acute Leukemia of Ambiguous Lineage: A Prospective, Single-arm, Multicenter Clinical Study

Acute leukemia of ambiguous lineage (ALAL), which refers to acute leukemia without definite evidence indicating cell differentiation along a specific lineage, mainly encompasses two major categories: acute undifferentiated leukemia (AUL) lacking the expression of lineage-specific antigens and mixed phenotype acute leukemia (MPAL) expressing antigens of two or more lineages. Despite certain advancements in basic research on ALAL, there is currently no unified treatment protocol for this disease. The majority of clinical studies are based on retrospective data, lacking prospective cohort studies. In terms of the overall treatment strategy, given the low chemotherapy remission rate, frequent relapses, and poor prognosis of ALAL, it should be treated as high-risk acute leukemia. Patients achieving complete remission should undergo allogeneic hematopoietic stem cell transplantation as soon as possible if conditions permit. Regarding chemotherapy regimens, the current main regimens utilized in clinical practice include ALL-like regimens, AML-like regimens, and hybrid therapies that incorporate both lymphoid and myeloid lineages. Based on existing research, international consensus guidelines recommend ALL-like regimens as the preferred induction treatment option for ALAL patients. In recent years, novel immunotherapy antibody drugs, such as Blinatumomab (a CD19-targeted drug), have achieved remarkable success in the treatment of B-ALL. However, for CD19+ ALAL, there is a lack of effective data regarding whether the first-line application of immunotherapy can further enhance therapeutic efficacy. Simultaneously, the novel small molecule drug venetoclax has demonstrated favorable therapeutic effects on various hematological malignancies. To enhance the overall therapeutic efficacy of adult ALAL in China, based on the above research, we have formulated a comprehensive treatment plan for adult ALAL, integrating Blinatumomab, ALL-like chemotherapy, venetoclax, and TKI drugs into the systemic treatment regimen, and exploring the safety and efficacy of this regimen in the treatment of adult ALAL.

开始日期2025-09-30

申办/合作机构

中国医学科学院血液病医院

NCT06570798

/ Recruiting临床2期

A Phase 2a, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

开始日期2025-06-14

申办/合作机构

Amgen, Inc.

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2025-12-31·Hematology

Blinatumomab added to conditioning regimen of allogeneic hematopoietic stem cell transplantation for adult MRD - positive acute lymphoblastic leukemia: a single-center case series

Article

作者: Zhang, Congxiao ; Zhao, Yanmin ; Shi, Jimin ; Liu, Meng ; Huang, He ; Yu, Jian ; Fu, Huarui ; Yang, Li ; Fu, Hui

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) remains the mainstay of treatment for adults with high-risk acute lymphoblastic leukemia (ALL). Due to the crucial role of measurable residual disease (MRD) before Allo-HSCT in predicting relapse and the promising anti-leukemia effect of blinatumomab, we documented a short-course, low-dose conditioning regimen incorporating blinatumomab for Allo-HSCT in three ALL patients with positive MRD. Following the administration of the blinatumomab-containing conditioning regimen, all patients attained complete remission (CR) with negative MRD status, and no severe adverse events were observed. After a 2-year follow-up, 2/3 of patients remained disease-free and attained long-term survival following transplantation. These cases indicated a short-term blinatumomab conditioning regimen may effectively prolong patient survival, improve prognosis, and offer a safe and cost-effective treatment for high-risk ALL patients with positive MRD. The addition of blinatumomab to the conditioning regimen of Allo-HSCT is feasible for high-risk ALL patients with positive MRD.

2025-08-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Recent development in bispecific antibody immunotherapy for hematological malignancies

Review

作者: Wang, Ke ; Guo, Xuejun ; Han, Lijie ; Yu, Jifeng ; Jiang, Zhongxing

While monoclonal antibody (mAb)-based therapies have revolutionized cancer treatment, challenges such as resistance mechanisms and tumor progression via alternative pathways underscore the need for novel therapeutic strategies. Bispecific antibodies (BsAbs), which target two distinct antigens simultaneously, represent a promising next-generation solution, improving therapeutic precision, efficacy, and safety. BsAbs also redirect cytotoxic effector cells to tumor sites, providing additional therapeutic mechanisms. Recent advancements in BsAb design, such as enhancements in pharmacokinetics and modular multi-specific formats, are expanding their use in hematological malignancies. Combining BsAbs with immune checkpoint inhibitors and other therapies may overcome resistance and improve clinical outcomes. Leading BsAbs, including mosunetuzumab, glofitamab, and blinatumomab, have demonstrated promising efficacy in clinical trials for leukemia and lymphoma subtypes. Despite remaining challenges, particularly in acute myeloid leukemia (AML), ongoing research into new targets and combination therapies is expected to enhance the efficacy of BsAbs in relapsed or refractory (R/R) disease. This review explores the structural and functional innovations of BsAbs, the challenges in current therapies, and their transformative potential in hematological malignancy immunotherapy.

2025-07-01·Nanomedicine-Nanotechnology Biology and Medicine

Two-component T-cell immunotherapy enables antigen pre-targeting to reduce cytokine release without forfeiting efficacy

Article

作者: Gambles, M Tommy ; Kopeček, Jindřich ; Sborov, Douglas ; Stark, Alex ; Spainhower, Kyle ; Li, Jiahui ; Bearss, David ; Kendell, Isaac ; Yang, Jiyuan ; Owen, Shawn

Contemporary T-cell immunotherapies, despite impressive targeting precision, are hindered by aberrant cytokine release and restrictive targeting stoichiometry. We introduce a two-component T-cell immunotherapy targeting B-cell malignancies: Multi-Antigen T-Cell Hybridizers (MATCH). This split antibody technology differs from current therapies by separating cancer cell-targeting components from T cell-engaging components. We demonstrate that this two-component structure facilitates tunable T-cell activation. αCD19 and αCD20 MATCH, administered in two steps, are both compared to the clinical standard bispecific antibody, blinatumomab. In vitro two-dimensional dose analysis and cytokine release data indicate MATCH improves cancer clearance with reduced cytokine release. Cytolytic mechanisms of action are evaluated. αCD20 MATCH anti-cancer efficacy is assayed using a human lymphoma murine model. Decreasing T-cell engager dose 10-fold yields comparable efficacy to non-reduced doses. Ultimately, this split-antibody paradigm may enhance antigen targeting while reducing cytokine release, with such safety and efficacy advantages augmented by the future possibility of multi-antigen targeting with MATCH.

468

项与贝林妥欧单抗相关的新闻（医药）

2025-05-30

·GlobeNewswire-Health Care

Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ® MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers

30 scientific abstracts will be presented using clonoSEQ for MRD assessment across multiple types of blood cancersSEATTLE, May 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). "The breadth of new MRD evidence being shared across various blood cancer types at ASCO and EHA this year highlights the transformative impact MRD is having on clinical care and drug development," said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. "These data presentations are a testament to the central role that clonoSEQ MRD testing now plays in clinical management and drug development across lymphoid cancers, particularly when combined with several clonoSEQ data presentations in diffuse large B-cell lymphoma (DLBCL) anticipated at the 18th International Conference on Malignant Lymphoma (iCML) on June 17-21, 2025 in Lugano, Switzerland." Selected presentations include: Data advancing the clinical actionability of clonoSEQ MRD testing Results from MIDAS, a phase 3 randomized study of 718 transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, demonstrate the use of MRD status to guide therapy post-induction. (ASCO Abstract 7500, June 3, 9:45-9:57 a.m. CDT, S100bc, McCormick Place Convention Center)Interim data from ADVANCE, a phase 2 randomized study of 306 transplant-eligible patients with NDMM shows the impact of MRD-guided assessments post-induction (ASCO Abstract 7503, June 3, 10:21-10:33 a.m. CDT, S100bc, McCormick Place Convention Center)Interim results from VENETOSTOP, a phase 2 study of 66 CLL patients, report the use of MRD status to shorten duration of venetoclax-based therapy. (EHA Abstract PS1568, June 14, 6:30 p.m. CEST, Poster Hall, Milano Convention Centre) Studies utilizing clonoSEQ MRD assessment as a critical indicator of quadruplet regimen efficacy in multiple myeloma Results from the phase 3 IsKia study of 151 transplant-eligible NDMM patients demonstrates increased rates of sustained MRD negativity at 10-6 with isatuximab plus carfilzomib, lenalidomide, and dexamethasone. (ASCO Abstract 7502, June 3, 10:09-10:21 a.m. CDT, S100bc, McCormick Place Convention Center) Follow-up data from PERSEUS, a phase 3 trial of 709 transplant-eligible patients with NDMM reports the impact of sustained MRD negativity status on progression free survival (PFS) with subcutaneous daratumumab plus bortezomib, lenalidomide and dexamethasone (D-VRd) induction and DR maintenance. (ASCO Abstract 7501, June 3, 9:57-10:09 a.m. CDT, S100bc, McCormick Place Convention Center) Results from DREAMM-8, a Phase 3 study in 302 patients with relapsed or refractory multiple myeloma, found superior PFS and higher MRD negativity rates in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) as compared to standard-of-care pomalidomide, bortezomib, and dexamethasone (PVd). (ASCO Abstract 7515, June 2, 9:00-9:06 a.m. CDT E450b, McCormick Place Convention Center) Data to be presented at ASCO: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaPoster Presentation6540Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL)Sunday, June 19 a.m.-12 p.m. CDTPoster Presentation6543Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute lymphoblastic leukemiaSunday, June 19 a.m.-12 p.m. CDTMultiple MyelomaOral Presentation7500*MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trialTuesday, June 39:45-9:57 a.m. CDTOral Presentation7501Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trialTuesday, June 39:57-10:09 a.m. CDTOral Presentation7502Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Tuesday, June 310:09-10:21 a.m. CDTOral Presentation7503*Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialTuesday, June 310:21-10:33 a.m. CDTOral Presentation7507*Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM)Tuesday, June 311:57 a.m.-12:09 p.m. CDTOral Presentation7515Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trialMonday, June 29-9:06 a.m. CDTOral Presentation7516Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS studyMonday, June 29:06-9:12 a.m. CDTASCO Oral Presentation7517*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ studyMonday, June 29:12-9:18 a.m. CDTPoster Presentation7529Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysisSunday, June 19 a.m.-12 p.m. CDTPoster Presentation7535Carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after autologous stem-cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM)Sunday, June 19 a.m.-12 p.m. CDTASCO Poster Presentation7551*Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysisSunday, June 19 a.m.-12 p.m. CDT Data to be presented at EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaOral PresentationS112Safety and efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL): results from a phase 1/2 dose expansion studySunday, June 1511:30-11:45 a.m. CESTOral PresentationS117Safety and efficacy of AZD0486 in adolescent and adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia: early results from the phase 1/2 SYRUS studyFriday, June 135:30-5:45 p.m. CESTPoster PresentationPF372Donor-derived, allogeneic CD19/CD22-CAR T cells with myeloablative graft-engineered Allo-HCT for high-risk B-ALLFriday, June 136:30 p.m. CESTChronic Lymphocytic LeukemiaPoster PresentationPF575Preliminary results of the ongoing multicenter, phase 2 study of retreatment with venetoclax plus obinutuzumab (ReVenG) in patients with recurrent chronic lymphocytic leukemia (CLL)Friday, June 136:30 p.m. CESTPoster PresentationPS1568Using minimal residual disease status to guide venetoclax treatment duration in patients with chronic lymphocytic leukemia: interim results from the phase II VENETOSTOP studySaturday, June 146:30 p.m. CESTFollicular LymphomaPoster PresentationPF881Epcoritamab monotherapy demonstrates deep and durable responses at 3-year follow-up in patients with relapsed/refractory follicular lymphomaFriday, June 136:30 p.m. CESTPoster PresentationPS21504-year update of phase 2 ELARA trial: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL)Saturday, June 146:30 p.m. CESTMantle Cell Lymphoma Poster PresentationPF882Minimal residual disease with bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: results from the phase 3 ECHO trialFriday, June 136:30 p.m. CESTMultiple MyelomaOral PresentationS201Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from IMMAGINE-1Saturday, June 145:15-5:30 p.m. CESTOral PresentationS205*Minimal residual disease-driven strategy following isatuximab-carfilzomib-lenalidomide-dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma: Primary endpoints of the phase 3 MIDAS trialSunday, June 1511:00-11:15 a.m. CESTOral Presentation S207*A randomized, multi-center study of carfilzomib, lenalidomide and dexamethasone (KRd) with or without daratumumab (D) for the treatment of patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trialSunday, June 1511:30-11:45 a.m. CESTOral PresentationS208*Analysis of sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial)Sunday, June 1511:45 a.m.-12 p.m. CESTPoster PresentationPF727Isa-vrd improves outcomes in high-risk (HR) newly diagnosed transplant-ineligible multiple myeloma (NDMM TI) using the IMS/IMWG consensus HR definition: results from the BENEFIT phase 3 trial (IFM 2020-05)Friday, June 136:30 p.m. CESTPoster Presentation PF729*Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): outcomes in patients with 1q21+ status in the phase 3 IMROZ studyFriday, June 136:30 p.m. CESTPoster PresentationPF750Isatuximab, bortezomib, lenalidomide, dexamethasone (Isa-VRd) in patients with transplant-ineligible (TI) newly diagnosed myeloma (NDMM) and plasmacytomas: IMROZ subgroup analysisFriday, June 136:30 p.m. CESTPoster PresentationPF754Interim analysis of MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after Auto-HCT in newly diagnosed multiple myelomaFriday, June 136:30 p.m. CESTPoster Presentation PS1722*Positron emission tomography with computed tomography and minimal residual disease for efficacy assessment in transplant-ineligible newly diagnosed myeloma patients: IMROZ analysisSaturday, June 146:30 p.m. CEST *Indicates data to be presented at both ASCO and EHA. About clonoSEQ clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL. clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request. To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary. About Adaptive Biotechnologies Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations and FP&A 201-396-1687 investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com

临床2期临床3期临床结果ASCO会议

2025-05-29

·PRNewswire

Miller Children's & Women's Hospital Contributes to Landmark Study Transforming Pediatric Leukemia Treatment

LONG BEACH, Calif., May 29, 2025 /PRNewswire/ -- The Jonathan Jaques Children's Cancer Institute at Miller Children's & Women's Hospital was involved in a pivotal Children's Oncology Group study that has reshaped the standard of care for children with B-cell acute lymphoblastic leukemia. The study, recently published in the New England Journal of Medicine, demonstrated that adding blinatumomab (BLINCYTO®) to chemotherapy significantly improves survival rates in children with B-cell acute lymphoblastic leukemia. Findings from the Children's Oncology Group's Phase III AALL1731 trial, sponsored by the National Cancer Institute's Cancer Therapy Evaluation Program, reveal that children receiving blinatumomab with chemotherapy had a three-year disease-free survival (DFS) rate of 96%, compared to 87.9% for those receiving chemotherapy alone. This marks a significant advancement in pediatric leukemia treatment, with a 61% reduction in the risk of relapse, secondary malignancy, or remission-related death. "The AALL1731 study results are truly practice-changing, further solidifying blinatumomab's role as the standard of care for a large number of children with B-ALL," says Sumit Gupta, M.D., Ph.D., FRCPC, co-chair of the Children's Oncology Group AALL1731 study and oncologist and clinician investigator, Division of Haematology/Oncology at The Hospital for Sick Children (SickKids) and associate professor of pediatrics at the University of Toronto. "These breakthrough data showing a significant improvement in disease-free survival are poised to bring substantial clinical value to children with newly diagnosed B-ALL." The success of the AALL1731 has reshaped treatment protocols world-wide, offering families new hope for improved survival rates and quality of life. "Children's Oncology Group protocols change how we treat children with cancer – this represents a landmark study integrating targeted therapy into standard chemotherapy," says Jacqueline Casillas, M.D., medical director, Jonathan Jaques Children's Cancer Institute, Miller Children's & Women's Hospital. "We are incredibly proud to have contributed to this groundbreaking research, which will help shape the future of pediatric cancer treatment and give more children the chance for long-term remission." Miller Children's & Women's Hospital has a dedicated team of physicians, nurse practitioners, nurses, and research coordinators who ensures rigorous adherence to all study protocols. Together, the hospital's multidisciplinary team consistently offers patients advanced treatment that can ultimately culminate in groundbreaking results like these. "What a privilege it has been to be involved in a Children's Oncology Group's trial that has redefined leukemia treatment," says Maki Okada, MS, CPNP-PC, FNP-BC, nurse practitioner, Miller Children's & Women's Hospital, co-study nurse for Children's Oncology Group AALL1731 study. As research continues to advance, the integration of targeted immunotherapies like blinatumomab is transforming pediatric leukemia care. It builds upon the progress of traditional chemotherapy to further enhance outcomes for young patients. "Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients," says Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children's Oncology Group, along with the patients, families, and clinical teams, for their dedication and partnership in advancing this critical study." Miller Children's & Women's Hospital remains dedicated to involvement in pediatric cancer research, actively contributing to studies that shape the future of treatment. As a proud member of the Children's Oncology Group, the hospital is committed to improving survival rates and outcomes for children facing cancer. About Miller Children's & Women's Hospital: Miller Children's & Women's Hospital (millerchildrens.org) is a part of MemorialCare, a not-for-profit, integrated healthcare system. As one of only eight free-standing children's hospitals in California, Miller Children's & Women's is recognized by U.S. News & World Report as a "Best Children's Hospital" for pediatric pulmonology and lung surgery. Regionally, it ranks among the top 10 in the state — treating more than 14,000 children each year — and has become a regional pediatric destination for more than 65,000 children requiring specialized outpatient care through its Cherese Mari Laulhere Children's Village Outpatient Center and satellite centers in Torrance, Fountain Valley, and Irvine. With maternal-fetal medicine specialists and neonatologists available 24/7, Miller Children's & Women's cares for birthing people with high-risk pregnancies and premature infants all under one roof. About The Children's Oncology Group (COG): COG (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Saudi Arabia in the fight against childhood cancer. Today, more than 80% of the 15,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 86%. COG's mission is to improve the cure rate and outcomes for all children with cancer. About Amgen: Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com. About AALL1731 (NCT03914625): The AALL1731 study was a Phase 3 randomized trial to determine if two non-sequential cycles of BLINCYTO added to chemotherapy improved disease-free survival (DFS) in children with newly diagnosed pediatric National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL). The study enrolled 4,264 newly diagnosed NCI SR B-ALL patients, of whom 2,334 were risk stratified at the end of induction therapy as either SR-Average or SR-High. At the first planned interim efficacy analysis (data cutoff June 30, 2024), 1,440 of the eligible and evaluable patients had been randomized. The AALL1731 study was designed and conducted independently from industry. The Cancer Therapy Evaluation Program (CTEP) of the NCI sponsored the trial and provided funding to the Children's Oncology Group to conduct the study. NCI is part of the National Institutes of Health (NIH). In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement. SOURCE Miller Children’s & Women’s Hospital WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期免疫疗法ASCO会议

2025-05-29

·PipelineReview

First patient dosed in YK012 trial-the world's first TCE therapy for primary membranous nephropathy

Key Highlights – Clinical trial to evaluate the safety and efficacy of YK012 in primary membranous nephropathy – Globally, this is the first bispecific CD19-directed CD3 T cell engager immunotherapy for this autoimmune disease – Milder T cell activation than Blincyto and Target cell-dependent T cell activation – Multiple CR cases observed in ongoing r/r NHL Phase Ia trial and r/r ALL Phase Ib/II trial HONG KONG, China I May 29, 2025 I Excyte, a global clinical-stage biotechnology company, announced first patient has been dosed for YK012, the world’s first patient T cell engager that entered into clinical trial for primary membranous nephropathy (pMN). The patient remained well after administration with no adverse reactions witnessed to date. pMN is an autoimmune disease caused by the attack of autoantibodies against podocyte antigens leading to the in situ production of immune complexes. pMN is the most common cause of primary nephrotic syndrome in non-diabetic adults worldwide, accounting for 20% to 37% of affected individuals, and as high as 40% in adults over 60 years of age (1). Currently, 20-30% of pMN cases are resistant to current therapies like rituximab and cyclophosphamide and relapse rates can be high (2). A clear regulatory pathway in this orphan disease in US could make YK012 one of the first approved TCE in the autoimmune space with many other autoimmune and oncology indications to follow. Excyte would file for US investigational new drug (IND) application imminently. The study aims to evaluate the safety, tolerability, and preliminary efficacy of YK012 in PMN patients. Led by Professor Minghui Zhao and Prof Zhao Cui from Peking University First Hospital, the trial is planned to be conducted across multiple centers in China. The clinical trial for this indication in the United States will be collaboratively executed by Excyte and its international partners. “YK012 is a T-cell engaging bispecific antibody targeting both CD19 and CD3, activating T-cell immunity via CD3 while targeting CD19—the most widely expressed tissue-specific marker during B-cell development and thereby enabling B-cell reset. Our data illustrated YK012 mediated significant B cell depletion and have illustrated in current clinical studies extended half-life and limited cytokine release in patients,” said Mr. Andrew Meng, chairman and COO at Excyte. “We look forward to collaborating with regulatory authorities to make YK012 available to this patient population with a high unmet medical need.” In December 2024, YK012 obtained Clinical Trial Approval Notice (No. CXSL2400727) from China’s National Medical Products Administration (NMPA) and was registered on ClinicalTrials.gov (NCT06982729). With the first patient dosed in pMN, Excyte now has a global presence in autoimmune diseases in additional to oncology indications such as NHL and ALL. Earlier this year, Excyte also secured clinical trial approval for systemic lupus erythematosus (SLE), with Professor Xiaofeng Zeng from Peking Union Medical College Hospital serving as Principal Investigator. About Excyte Biopharma Ltd. Excyte Ltd. was co-founded by Dr Qing’an Yuan and Mr Andrew Meng , biotech industry veterans with decades of antibody engineering experiences. The company has also established a U.S.-based wholly-owned subsidiary, Excyte LLC, forming a dual-engine drug R&D hub spanning China and the U.S. Excyte is dedicated to developing innovative bispecific antibody drugs for hematologic cancers, multiple myeloma, solid tumors, autoimmune diseases, and other conditions. Excyte’s FIST platform and next generation assets possess features such as long-acting, low-toxicity, and high-yield technological innovations. For more information, please visit https://www.iExcyte.com/ References: 1.William G Couser, Primary Membranous Nephropathy, Clin J Am Soc Nephrol. 2017 May 26;12(6):983–997. 2.Elham Ahmadian, Seyed Mahdi Hosseiniyan Khatibi, Sepideh Zununi Vahed, Mohammadreza Ardalan, Novel treatment options in rituximab-resistant membranous nephropathy patients, International Immunopharmacology, Volume 107, 2022, 108635, ISSN 1567-5769. SOURCE: Excyte Pharma

免疫疗法临床1期临床申请

100 项与贝林妥欧单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09325	贝林妥欧单抗	L01XC19	DB09052

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性 B 细胞急性淋巴细胞白血病	日本	Amgen, Inc.	2018-09-21
难治性 B 细胞急性淋巴细胞白血病	日本	Amgen, Inc.	2018-09-21
急性淋巴细胞白血病	加拿大	Amgen Canada, Inc.	2015-12-22
CD19阳性前体B细胞急性淋巴细胞白血病	欧盟	Amgen Europe BV	2015-11-23
CD19阳性前体B细胞急性淋巴细胞白血病	冰岛	Amgen Europe BV	2015-11-23
CD19阳性前体B细胞急性淋巴细胞白血病	列支敦士登	Amgen Europe BV	2015-11-23
CD19阳性前体B细胞急性淋巴细胞白血病	挪威	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	欧盟	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	冰岛	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	列支敦士登	Amgen Europe BV	2015-11-23
费城染色体阳性成人前体急性淋巴细胞白血病	挪威	Amgen Europe BV	2015-11-23
费城染色体阴性急性淋巴细胞白血病	澳大利亚	Amgen Australia Pty Ltd.	2015-11-09
费城染色体阳性急性淋巴细胞白血病	澳大利亚	Amgen Australia Pty Ltd.	2015-11-09
前体B细胞急性淋巴细胞白血病	美国	Amgen, Inc.	2014-12-03

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
Ph样急性淋巴细胞白血病	临床3期	美国	National Cancer Institute	2025-05-30
BCR-ABL1阳性急性淋巴细胞白血病	临床3期	美国	National Cancer Institute	2021-01-25
BCR-ABL1阳性急性淋巴细胞白血病	临床3期	以色列	National Cancer Institute	2021-01-25
BCR-ABL1阳性急性淋巴细胞白血病	临床3期	波多黎各	National Cancer Institute	2021-01-25
B淋巴细胞白血病淋巴瘤	临床3期	美国	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	澳大利亚	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	加拿大	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	新西兰	National Cancer Institute	2019-07-03
B淋巴细胞白血病淋巴瘤	临床3期	波多黎各	National Cancer Institute	2019-07-03
唐氏综合征	临床3期	美国	National Cancer Institute	2019-07-03

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02811679 (CTgov)	临床2期	难治性惰性非霍奇金淋巴瘤	13	blinatumomab	築淵積鹹鏇鏇鹽觸製構 = 觸觸願憲鹽觸鬱觸艱餘簾製鏇淵齋鬱遞壓蓋憲 (製窪網獵構遞廠鹽積齋, 壓夢顧觸鬱選選鑰構夢 ~ 壓膚構獵鏇鬱願壓餘網) 更多	-	2025-05-23
NCT04506086 (CTgov)	临床4期	残留肿瘤 \| 前体B细胞急性淋巴细胞白血病	10	Current Wearable Heatlth Monitoring System (CWHMS)+Blinatumomab	觸壓繭簾鏇鏇艱衊齋築 = 鬱顧選顧積選廠繭糧獵膚壓襯簾壓願膚膚願壓 (鬱鹽製糧醖鹽鹹選觸餘, 遞築糧壓窪衊積製醖淵 ~ 鬱願網製憲廠糧願壓艱) 更多	-	2025-05-18
NCT04556084 (CTgov)	临床2期	CD19阳性B细胞急性淋巴细胞白血病 \| 复发性 B 细胞急性淋巴细胞白血病 \| 胃肠结石 ... 更多	2	blinatumomab	構構餘獵顧憲鏇鹹膚鑰 = 艱遞積網壓衊醖築鹹夢醖鹽淵壓鹽範鏇廠鬱淵 (淵糧築餘糧願築顧鏇選, 範選鑰衊繭憲壓鏇繭衊 ~ 醖願襯艱夢鹹網艱鬱鏇) 更多	-	2025-05-13
NCT03914625 (AALL1731, Pubmed \| N Engl J Med) 人工标引	临床3期	前体B细胞急性淋巴细胞白血病	1,440	Blinatumomab + Chemotherapy	願廠積構鬱夢艱網簾構(襯築簾選壓積餘鹹觸艱) = 鑰餘構鹹淵製艱艱願範鏇膚膚簾襯積襯製淵製 (鏇顧遞艱顧簾鬱壓鏇衊, 1.2) 更多	积极	2025-02-27
				Chemotherapy alone	願廠積構鬱夢艱網簾構(襯築簾選壓積餘鹹觸艱) = 憲觸憲蓋鹽構遞願鹹壓鏇膚膚簾襯積襯製淵製 (鏇顧遞艱顧簾鬱壓鏇衊, 2.1) 更多
NCT02003222 (E1910, PRNewswire) 人工标引	临床3期	CD19阳性前体B细胞急性淋巴细胞白血病巩固 CD19 Positive	-	BLINCYTO® (blinatumomab) +multiphase consolidation chemotherapy	衊襯獵鏇築膚積餘網鑰(觸築繭觸襯醖蓋構網齋) = 鏇構鏇鏇鹹願範鹽願選窪製蓋積蓋構壓網簾憲 (窪衊窪衊鑰製觸糧醖齋 )	积极	2025-01-29
				Chemotherapy alone	衊襯獵鏇築膚積餘網鑰(觸築繭觸襯醖蓋構網齋) = 簾簾艱艱遞窪壓蓋繭願窪製蓋積蓋構壓網簾憲 (窪衊窪衊鑰製觸糧醖齋 )
NCT03914625 (AALL1731, ASH2024 \| Literature) 人工标引	临床3期	前体B细胞成淋巴细胞白血病淋巴瘤一线 BCR::ABL1 negative	2,245	standard-intensity chemo alone	選淵蓋網艱膚壓蓋網鬱(夢選壓衊鏇廠範繭觸製) = 獵遞艱積簾觸構願積鬱糧範鑰獵鏇願鹽願鏇衊 (觸範衊艱鏇積襯淵積糧, 2.1)	积极	2024-12-08
				standard-intensity chemo alone + blinatumomab	選淵蓋網艱膚壓蓋網鬱(夢選壓衊鏇廠範繭觸製) = 糧淵鑰鏇窪願壓窪糧醖糧範鑰獵鏇願鹽願鏇衊 (觸範衊艱鏇積襯淵積糧, 1.2)
ASH2024	N/A	CD19阳性B细胞急性淋巴细胞白血病	-	Inotuzumab ozogamicin (InO)	鏇膚選顧膚繭齋醖遞鑰(膚選齋淵艱廠網選壓廠) = 16 (53%) and 2 (7%) developed CRS of any grade and grade 3 to 4, respectively, and 4 (13%) and 1 (3%) developed immune effector cell-associated neurotoxicity syndrome of any grade and grade 3, respectively 糧糧網願獵遞憲鹹憲選 (鑰蓋淵廠網鏇範鹽夢糧 ) 更多	-	2024-12-08
				Blinatumomab (Blina)
NCT04521231 (ASH2024) 人工标引	临床1期	前体B细胞急性淋巴细胞白血病	27	Subcutaneous Blinatumomab 250μg/500μgBlinatumomab 250μg/500μg	鏇獵遞廠範醖觸憲鹹憲(齋廠衊網遞齋鏇淵鏇夢) = 糧築構夢顧膚簾艱選鬱構遞齋憲壓願製壓窪觸 (繭淵遞顧壓顧蓋憲積觸 ) 更多	积极	2024-12-07
				Subcutaneous Blinatumomab 500μg/1000μgBlinatumomab 500μg/1000μg	鏇獵遞廠範醖觸憲鹹憲(齋廠衊網遞齋鏇淵鏇夢) = 壓築廠鏇構齋築鑰獵餘構遞齋憲壓願製壓窪觸 (繭淵遞顧壓顧蓋憲積觸 ) 更多
NCT02879695 (CTgov)	临床1期	复发性 B 细胞急性淋巴细胞白血病 \| 难治性混合表型急性白血病 \| 难治性 B 细胞急性淋巴细胞白血病 ... 更多	28	Nivolumab+Blinatumomab (Dose Level A1)	餘鑰範網衊顧繭製遞蓋(餘壓築鹽顧鹹窪夢齋簾) = 鹽窪醖積獵淵壓網築憲壓範鏇願壓糧窪觸衊衊 (鹹遞襯構觸衊願夢窪獵, 夢壓壓鏇憲鏇鑰鑰積網 ~ 簾齋衊範簾鹽壓構鏇網) 更多	-	2024-10-16
				Ipilimumab+Nivolumab+Blinatumomab (Dose Level B1)	餘鑰範網衊顧繭製遞蓋(餘壓築鹽顧鹹窪夢齋簾) = 蓋齋積積糧壓獵獵鹽蓋壓範鏇願壓糧窪觸衊衊 (鹹遞襯構觸衊願夢窪獵, 鬱蓋淵築壓艱鹹廠顧窪 ~ 糧膚鹹鑰衊鹽壓膚範簾) 更多
ALL-808 (SOHO2024)	临床2期	复发性儿童急性淋巴细胞白血病	22	Mini-Hyper-CVD-Inotuzumab-Blinatumomab	範鏇夢膚壓醖蓋廠衊艱(遞鹽糧鏇襯鹹築鬱獵願) = 願願膚獵廠鏇淵襯鹽範糧糧製網鑰夢積艱網觸 (範繭簾遞鏇鏇築製積糧 ) 更多	积极	2024-09-04