Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.

开始日期2026-02-07

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06815003

/ Not yet recruiting临床2期IIT

Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation

This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.

开始日期2026-01-08

申办/合作机构

City of Hope National Medical Center

[+1]

NCT05521087

/ Withdrawn临床1期

A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

开始日期2025-12-26

申办/合作机构

Janssen Research & Development LLC

100 项与淋巴细胞白血病相关的临床结果

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100 项与淋巴细胞白血病相关的转化医学

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0 项与淋巴细胞白血病相关的专利（医药）

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99,179

项与淋巴细胞白血病相关的文献（医药）

2025-12-31·Hematology

Identification of t(X;1)(q28;q21) generating a novel GATAD2B::MTCP1 gene fusion in CMML and its persistence during progression to AML

Article

作者: Chen, Su-ning ; Chen, Yu ; Liu, Yi-zi ; Zhang, Zhi-yu ; Hou, Chun-xiao ; Zhang, Feng-hong ; Wang, Qian ; Zhu, Yi-yan

OBJECTIVEHematological malignancies often involve chromosomal translocations and fusion genes that drive disease progression. While MTCP1 is well-known in T-cell prolymphocytic leukemia (T-PLL), its role in myeloid neoplasms is less understood. This report presents the first identification of the t(X;1)(q28;q21) translocation leading to the GATAD2B::MTCP1 fusion in acute myeloid leukemia (AML) transformed from chronic myelomonocytic leukemia (CMML).METHODSThe karyotypes were described according to the International System for Human Cytogenetic Nomenclature 2009. We performed targeted next-generation sequencing (NGS) on a panel of 172 genes commonly mutated in hematological malignancies (Supplemental Table 1), using an Illumina platform. RNA sequencing was conducted on total RNA extracted from bone marrow, also using the Illumina platform. The GATAD2B::MTCP1 fusion gene was confirmed by reverse transcription-polymerase chain reaction (RT-PCR) and Sanger sequencing, with specific primers for the fusion transcript (GATAD2B-F: CCTCTTTTTTTCGACGCC; MTCP1-R: ACTGAGCACAACACTTACGC).RESULTSThe GATAD2B::MTCP1 fusion results from a breakpoint on 1q21 within GATAD2B exon 1 and Xq28 within MTCP1 exon 2. The patient with the GATAD2B::MTCP1 fusion exhibited disease progression from CMML to AML. Despite achieving initial remission with venetoclax-based therapy and allo-HSCT, the patient relapsed and died.CONCLUSIONSWe propose that the GATAD2B::MTCP1 fusion upregulates MTCP1 expression rather than generating a fusion protein, thereby contributing to transformation and relapse in AML. Further investigations are needed to elucidate the precise role of this fusion event in myeloid malignancies.

2025-12-31·Cancer Biology & Therapy

The mitochondria as an emerging target of self-renewal in T-cell acute lymphoblastic leukemia

Review

作者: Al-Hamaly, Majd A ; Winter, Evelyn ; Blackburn, Jessica S

Acute lymphocytic leukemia (ALL) is the most common leukemia in children, with the T-cell subtype (T-ALL) accounting for 15% of those cases. Despite advancements in the treatment of T-ALL, patients still face a dismal prognosis following their first relapse. Relapse can be attributed to the inability of chemotherapy agents to eradicate leukemia stem cells (LSC), which possess self-renewal capabilities and are responsible for the long-term maintenance of the disease. Mitochondria have been recognized as a therapeutic vulnerability for cancer stem cells, including LSCs. Mitocans have shown promise in T-ALL both in vitro and in vivo, with some currently in early-phase clinical trials. However, due to challenges in studying LSCs in T-ALL, our understanding of how mitochondrial function influences self-renewal remains limited. This review highlights the emerging literature on targeting mitochondria in diverse T-ALL models, emphasizing specific mitochondrial vulnerabilities linked to LSC self-renewal and their potential to significantly improve T-ALL treatment.

2025-12-31·Hematology

Association between ABCB1 C3435 T polymorphism- and methotrexate-related toxicity in pediatric acute lymphoblastic leukemia: a meta-analysis

Review

作者: Wang, Gang ; Wang, Jiaheng ; Zhang, Nana ; Yan, Xuefen

BACKGROUNDThe effect of methotrexate (MTX)-related toxicity on childhood acute lymphoblastic leukemia (ALL) is controversial. Hence, this meta-analysis aimed to investigate the association between ABCB1 C3435 T polymorphism- and methotrexate-related toxicity in pediatric acute lymphoblastic leukemia.METHODSRelevant studies were systematically searched and extracted from multiple databases including PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang databases up to 1 June, 2024.RESULTSA total of 13 articles met the criteria, including 1506 patients. The results showed that ABCB1 C3435 T polymorphism was significantly associated with MTX-induced hepatotoxicity (CT/TT vs. CC: OR: 2.15, 95% CI: 1.40-3.32). There was no significant difference between ABCB1 C3435 T polymorphism and mucositis, myelosuppression, nephrotoxicity, gastrointestinal toxicity in pediatric ALL treated with MTX.CONCLUSIONSOur meta-analysis suggests that the ABCB1 C3435 T mutation may enhance the MTX-induced hepatotoxicity in childhood acute lymphoblastic leukemia.

5,617

项与淋巴细胞白血病相关的新闻（医药）

2025-05-05

·药通社

第二十一家被驳回，该品种原研即将上市！

统计每周药品获批、上市申请、临床申请及审批情况（2025.4.26-2025.5.2）注：周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。本周工作日只有四天，无新药获批上市，但有几款新药的上市申请被受理。百济神州申报的索托克拉片的上市申请获得受理。该上市申请已经被CDE正式纳入优先审评，适用于治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）/ 小淋巴细胞淋巴瘤（SLL）成人患者。公开资料显示，索托克拉片（sonrotoclax）是百济神州在研的新一代BCL2抑制剂。诺华（Novartis）申报的镥[177Lu] 特昔维匹肽注射液一项新适应症上市申请获得受理。诺华（Novartis）申报的镥[177Lu] 特昔维匹肽注射液一项新适应症上市申请获得受理。一致性评价过评仅5个品种，无首家过评，驳回倒是很多，30日发放12个品种的通知件，多个知名品种均被驳回。乙酰半胱氨酸注射液，驳回已经是第二十一家了。该品种过评真是一波三折，不过好消息是乙酰半胱氨酸注射液的原研进度可喜，Zambon已于4月24日完成了资料补充，离获批不远了。企业可以等原研获批之后，再来仿制。扫码加入药通社交流群！1、仿制药一致性评价过评&驳回情况2、仿制药一致性评价申报情况3、新药申请上市情况（含申请进口和申请增加适应症）4、批准临床(默示许可)5、申请临床情况投稿/企业合作/内容沟通：华籍美人（Ww_150525）*添加请注明备注及来意

一致性评价上市批准优先审批临床研究

2025-05-05

·药时代

3718.5亿美元！全球50款最畅销的重磅药物泽布替尼已具上榜实力可排第49名

正文共： 2046字 3图预计阅读时间： 6分钟（图片来源：Pharma Dive）不久前，全球知名媒体Pharma Dive基于2024年年度销售额数据更新了全球Top50重磅药物名单，药时代团队对这份名单进行了较为系统、细致的梳理和有趣的分析。目前里面没有中国公司的产品，本来我们相信，用不了多久，中国公司的产品将榜上有名。可分析之后发现，原来中国公司已经具备上榜的实力了！现在开始逐步分享，希望对广大中国企业和朋友们有点滴参考价值。欢迎批评指正！多谢！销售额合计3718.5亿美元，平均每款74.37亿美元既然上面提到目前排行榜上没有中国药企及其产品，那么就要知道标准是什么，目前的差距有多大。50款重磅药物2024年的年度销售额合计3718.5亿美元，所以平均每款74.37亿美元，中位数59.15亿美元。全球年度销售额排行榜的最高是来自默沙东的新晋药王Keytruda（K药），为294.8亿美元，最低的是来自艾伯维的治疗慢性淋巴细胞白血病的小分子BCL-2抑制剂唯可来（维奈克拉），为25.8亿美元。所以，这份排行榜的门槛就是25.8亿美元。现在，我们基于搜索到的信息来看看中国药企的实力和上榜的可能性。百济神州研发的针对套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病（CLL）等一系列适应症的BTK抑制剂泽布替尼（Zanubrutinib，商品名：Brukinsa）是首个在美国获批的中国抗癌药，凭借优于伊布替尼的疗效数据快速放量。根据2024年百济神州全年业绩公告，其核心产品泽布替尼（商品名百悦泽）的全球销售额为‌26.44亿美元‌（约合人民币188.59亿元），同比增长105%，占公司总营收的69.3%。如果采用26.44亿美元这个数据，那么百济神州的泽布替尼不仅可以上榜，而且可以位居第49名，取代阿斯利康的C5补体蛋白产品舒立瑞，因为后者2024年的销售额是25.9亿美元，这也意味着，艾伯维的唯可来（维奈克拉）将被挤出TOP50排行榜。百济神州的另一款重磅产品，治疗非小细胞肺癌、霍奇金淋巴瘤的PD-1抑制剂替雷利珠单抗（Tislelizumab，商品名：百泽安）通过与诺华合作拓展欧美市场，2024年全球销售额约6.21亿美元。另一款来自中国的PD-1抑制剂则是信达生物的信迪利单抗（Sintilimab，商品名：达伯舒）。信达负责大中华区市场，海外授权礼来共同开发，虽然美国上市受阻，但东南亚市场增长。2024年全球销售额：约5.26亿美元。有实力冲击排行榜的后备军包括：恒瑞医药的PD-1抑制剂卡瑞利珠单抗（Camrelizumab，商品名：艾瑞卡）获批的适应症主要包括肝癌、食管癌，面临的挑战包括国内集采降价压力，海外布局取得新进展很关键。复星医药的复必泰（mRNA新冠疫苗，与BioNTech合作），2024年全球销售额因疫情需求减少较2023年下降，市场主要在中国港澳台及东南亚地区。恒瑞医药的吡咯替尼（Pyrotinib，商品名：艾瑞妮），针对HER2阳性乳腺癌，是中国首个原创HER2靶向药，东南亚市场表现亮眼。康方生物的卡度尼利单抗（PD-1/CTLA-4双抗，AK104），作为全球首个PD-1/CTLA-4双抗，定价优势显著。信达生物的PCSK9抑制剂信必乐（IBI306），中国首个自主研发的PCSK9抑制剂，2023年8月获批上市，主打适应症高胆固醇血症，定价更低（年治疗费用约2万元人民币，仅为进口药的1/3）。中国新药全球化的挑战与机遇“不出海，就出局。要上榜，先出海！”现在，中国制药界已经达成以上共识。中国创新药全球化面临专利布局、市场竞争和政策环境的多重考验，加速海外临床和商业化进程仍是关键挑战；在PD-1、GLP-1、ADC、TCE等拥挤赛道中，差异化布局成为突破口。国内集采政策倒逼药企转向创新与国际化，而欧美市场之外其它国家和地区的准入则是下一步发展的核心。药时代将持续跟踪报道，欢迎广大朋友们关注、批评指正！参考资料：Pharma Dive官网38笔！596亿美元！跨国药企2025年重磅交易达成，中国公司贡献很大关税阴云下，大型药企并购热情不减，哪些中国药企可能被收购？2024年制药行业并购TOP1028.4亿美元！4月中国创新药出海汇总其它公开资料图片来源：微信订阅号AI38笔！596亿美元！跨国药企2025年重磅交易达成，中国公司贡献很大2025-05-02【直击现场】「星起点」宣讲会直播：50万资金+专家辅导，寻找下一个代谢病创新药突破者！2025-04-30百济神州索托克拉冲刺上市，引领BCL2抑制剂新纪元！2025-04-30版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩!

财报上市批准医药出海

2025-05-05

·Pharmaceutical Technology

Chinese regulator grants priority review for InnoCare’s solid tumour treatment

The therapy is intended for individuals suffering from advanced solid tumours with neurotrophic tyrosine receptor kinase fusion genes. Credit: Chay_Tee/Shutterstock. China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma’s zurletrectinib (ICP-723) for advanced solid tumours harbouring neurotrophic tyrosine receptor kinase (NTRK) fusion genes. Previously, the CDE had accepted the new drug application (NDA) for the pan-tropomyosin receptor kinase (TRK) inhibitor, which demonstrated better safety and efficacy in a registration clinical trial. InnoCare Pharma CEO, chairman, and co-founder Dr Jisong Cui said: “I am very pleased that zurletrectinib has been included in the priority review. As a new broad-spectrum anticancer drug, zurletrectinib has demonstrated outstanding efficacy and safety. “We look forward to bringing better treatment options to patients with solid tumours as soon as possible.” In January last year, the company dosed the first paediatric subject with zurletrectinib at the Sun Yat-sen University Cancer Center in China, launching clinical research for children aged 2 to 12 years. This milestone followed good efficacy and safety results in adults and adolescents aged 12 to 18 years. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Last month, the NMPA approved the company’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib as a first-line treatment for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The therapy is now approved for three indications: relapsed and refractory (R/R) CLL/SLL, R/R marginal zone lymphoma (R/R MZL) and R/R mantle cell lymphoma (R/R MCL). The company’s portfolio includes various new drug products at clinical, preclinical research and development, and commercialisation stages. It operates out of branches in China, Hong Kong, and the US.

优先审批上市批准申请上市