An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma

This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma.

开始日期2021-03-02

申办/合作机构

Curocell, Inc.

100 项与安基奥仑赛相关的临床结果

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100 项与安基奥仑赛相关的转化医学

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100 项与安基奥仑赛相关的专利（医药）

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项与安基奥仑赛相关的文献（医药）

2023-06-01·HEMATOLOGICAL ONCOLOGY

PHASE 2 STUDY OF ANBAL‐CEL, NOVEL ANTI‐CD19 CAR‐T THERAPY WITH DUAL SILENCING OF PD‐1 AND TIGIT IN RELAPSED OR REFRACTORY LARGE B CELL LYMPHOMA ‐ INTERIM ANALYSIS RESULT

Article

作者: Jung, J. ; Kim, J. ; Lee, H. ; Yoon, S. ; Yoon, S. E. ; Kim, S. J. ; Koh, Y. ; Kim, W. ; Eom, H. ; Yoon, D. H. ; Yang, D. ; Cho, H.

2021-06-01·The Lancet. Oncology1区 · 医学

Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial

1区 · 医学

Article

作者: Fortunato Ciardiello ; Eriko Yamamoto ; Kanwal Raghav ; Javier Rodriguez ; Tomohiro Nishina ; Kensei Yamaguchi ; Destiny-Crc investigators ; Fotios Loupakis ; Hisato Kawakami ; Javad Shahidi ; Toshiki Masuishi ; Ki Chung ; Andrea Sartore-Bianchi ; Yoshito Komatsu ; Yasuyuki Okuda ; Maria Di Bartolomeo ; Elena Elez ; Axel Grothey ; Marwan Fakih ; Taito Esaki ; Salvatore Siena ; Takayuki Yoshino ; Kapil Saxena ; Zev Wainberg ; Emarjola Bako

BACKGROUND:

HER2 amplification has been identified in 2-3% of patients with colorectal cancer, although there are currently no approved HER2-targeted therapies for colorectal cancer. We aimed to study the antitumour activity and safety of trastuzumab deruxtecan (an antibody-drug conjugate of humanised anti-HER2 antibody with topoisomerase I inhibitor payloads) in patients with HER2-expressing metastatic colorectal cancer.

METHODS:

DESTINY-CRC01 is an open-label, phase 2 study that recruited patients from 25 clinics and hospitals in Italy, Japan, Spain, the UK, and the USA. Eligible patients had centrally confirmed HER2-expressing metastatic colorectal cancer that had progressed on two or more previous regimens (HER2-targeted therapies other than trastuzumab deruxtecan permitted), were aged 18 years or older (≥20 years in Japan), had an Eastern Cooperative Oncology Group score of 0 or 1, and had RAS and BRAF^V600E wild-type tumours. Patients were enrolled into one of three cohorts by HER2 expression level: cohort A (HER2-positive, immunohistochemistry [IHC] 3+ or IHC2+ and in-situ hybridisation [ISH]-positive), cohort B (IHC2+ and ISH-negative), or cohort C (IHC1+). Patients received 6·4 mg/kg trastuzumab deruxtecan intravenously every 3 weeks until disease progression, unacceptable adverse events, withdrawal of consent, or death. The primary endpoint was confirmed objective response rate in cohort A by independent central review which was assessed in the full analysis set and safety was assessed in the safety analysis set. Both the full analysis set and the safety analysis set included all patients who received one or more doses of trastuzumab deruxtecan. This ongoing trial is registered with ClinicalTrials.gov, number NCT03384940.

FINDINGS:

Between Feb 23, 2018, and July 3, 2019, 78 patients were enrolled in the study (53 in cohort A, seven in cohort B, and 18 in cohort C), all of whom received at least one dose of study drug. For the 53 (68%) patients with HER2-positive tumours (cohort A), a confirmed objective response was reported in 24 (45·3%, 95% CI 31·6-59·6) patients after a median follow-up of 27·1 weeks (IQR 19·3-40·1). Grade 3 or worse treatment-emergent adverse events that occurred in at least 10% of all participants were decreased neutrophil count (17 [22%] of 78) and anaemia (11 [14%]). Five patients (6%) had adjudicated interstitial lung disease or pneumonitis (two grade 2; one grade 3; two grade 5, the only treatment-related deaths).

INTERPRETATION:

Trastuzumab deruxtecan showed promising and durable activity in HER2-positive metastatic colorectal cancer refractory to standard treatment, with a safety profile consistent with that reported in previous trastuzumab deruxtecan trials. Interstitial lung disease and pneumonitis are important risks requiring careful monitoring and prompt intervention.

FUNDING:

Daiichi Sankyo.

项与安基奥仑赛相关的新闻（医药）

2023-12-18

·药明康德

GLP-1基因疗法减重27%，缓解率达100%的CAR-T疗法

近期，全球细胞和基因疗法（CGT）领域迎来系列进展。其中：CAR-T疗法不但在治疗多发性骨髓瘤的临床试验中达到100%的总缓解率，在治疗自身免疫疾病的临床试验中也让所有患者症状达到持续缓解。基于GLP-1受体激动剂的基因疗法在动物实验中将体重降低27%，带来无需长期接受治疗就可维持减重的希望。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。 ◇德国埃尔兰根大学医院（University Hospital Erlangen）研究人员在2023美国血液学会（ASH）年会上，公布了靶向CD19的CAR-T疗法治疗自身免疫性疾病患者的研究结果。该试验入组系统性红斑狼疮（SLE）、特发性炎性肌炎（IIM）和系统性硬化症（SSc）难治性患者，这些患者有活动性器官受累的迹象、经历多种免疫调节疗法失败且其疾病严重、有立即危及生命的可能。共有15例患者（8例SLE、4例SSc和3例IIM）接受了CAR-T细胞单次输注治疗。分析显示，所有8名SLE患者在3个月后均达到完全缓解，并自此维持SLE疾病活动指数（SLEDAI）为0。3/3的IIM患者在3个月后体内肌酸肌酶（CK）水平呈现显著改善和正常化，且这一情况仍在持续中。在4名SSc患者中，根据欧洲抗风湿病联盟（EULAR）标准，3名随访时间超过3个月患者的疾病活动性降低了4.3。所有15例患者均完全停止使用免疫抑制药物。◇Arcellx公布了旗下细胞疗法CART-ddBCMA（现名为anitocabtagene autoleucel，anito-cel）治疗多发性骨髓瘤的1期扩展研究的最新临床数据。试验结果显示，患者的客观缓解率（ORR）达到100%，38例可评估患者中有29例获得了完全缓解（CR）或严格的完全缓解（sCR）（>CR率，76%）。38例患者中有35例获得了非常好的部分缓解或更高水平的缓解（>VGPR率，92%）。 ◇Affimed在ASH年会上宣布了其先天细胞衔接蛋白（ICE）acimtamig，与同种异体自然杀伤（NK）细胞联用的最新临床试验数据。数据显示，在接受2期临床试验推荐剂量（RP2D）的复发/难治性霍奇金淋巴瘤（HL）患者中，客观缓解率达97%，完全缓解率高达78%。 Acimtamig是一款潜在“first-in-class"的先天细胞衔接蛋白，可独特地激活先天免疫系统破坏CD30阳性血液肿瘤。Acimtamig通过结合并激活自然杀伤细胞和巨噬细胞，利用先天免疫系统的力量，诱导CD30阳性肿瘤细胞的特异性和选择性杀伤。 ◇Poseida Therapeutics宣布了与罗氏（Roche）共同开发的同种异体CAR-T疗法P-BCMA-ALLO1的1期临床试验的早期疗效和安全性结果，该疗法用于治疗复发/难治性多发性骨髓瘤患者。分析显示，在接受充分淋巴细胞耗竭的强化预治疗患者中，接受CAR-T疗法P-BCMA-ALLO1治疗患者的ORR为82%（n=9/11），并具有深度临床缓解。而在既往未接受过BCMA靶向双特异性T细胞衔接抗体治疗患者的ORR则为100%。 ◇Editas Medicine公司在ASH年会上公布了17例患者接受CRISPR基因编辑疗法EDIT-301治疗的最新安全性和有效性数据，EDIT-301又称为renizgamglogene autogedtemcel（reni-cel），在RUBY试验中用于治疗严重镰刀型细胞贫血病（SCD）（n=11），在EdiTHAL试验中用于治疗输血依赖性β地中海贫血（TDT）（n=6）。试验结果显示，在RUBY试验中，所有患者均未发生血管闭塞事件（VOE）。在EdiTHAL试验中，所有患者的总血红蛋白均早期稳健升高，高于输血非依赖性阈值9 g/dL（n=6）。 ◇Obsidian Therapeutics公司公布了其工程化肿瘤浸润淋巴细胞（TIL）疗法OBX-115治疗晚期或转移性黑色素瘤的积极1期临床试验结果。中位随访时间为18周时，在对PD-1抑制剂耐药的6名患者中，ORR达到50%，完全缓解率为33%，疾病控制率为100%。 OBX-115是一款表达与细胞膜结合的IL-15的工程化TIL细胞疗法。它无需使用高剂量IL-2激活和扩增TIL细胞，减轻了疗法的潜在毒性。安全性方面，目前尚未观察到剂量限制毒性，治疗后出现的不良事件与淋巴细胞清除的特征一致。 ◇Carisma Therapeutics宣布，确定该公司与Moderna公司研发合作中的首款体内CAR巨噬细胞（CAR-M）候选疗法。这款疗法靶向具有显著未竟医疗需求的实体瘤上一个尚未公开的靶点。Carisma和Moderna的研发合作利用Moderna的脂质纳米颗粒（LNP）技术在体内制造CAR-M细胞。近日发表的临床前概念验证实验数据显示，Moderna公司使用LNP装载的优化mRNA能够在动物体内将髓系细胞重新定向，展现出抗肿瘤活性。在2022药明康德全球论坛上，Carisma公司首席医学官Debora Barton博士表示，在实体瘤的微环境中，T细胞耗竭，同时巨噬细胞大量存在，因此，对于实体瘤的治疗，探索CAR-M是有意义的。 ◇Fractyl Health日前在2023年世界胰岛素抵抗、糖尿病和心血管疾病大会上展示了其Rejuva基因治疗平台的临床前研究成果。在啮齿类动物肥胖模型中，该公司开发的基因疗法GLP-1 PGTx单剂输注后28天，将小鼠体重降低27%，而持续接受司美格鲁肽（10 nmol/kg/day）治疗的对照组在同一阶段体重降低21%。这一差异具有统计学显著性。这些发现表明，针对性的GLP-1 PGTx递送可以在肥胖动物中通过仅一次给药实现持久的减重。目前获批的GLP-1受体激动剂需要患者长期接受注射或者口服疗法，一旦停药，体重可能会逐渐反弹。GLP-1 PGTx是一款基于腺相关病毒（AAV）载体的基因疗法，目标是在胰岛素启动子的驱动下，在胰岛β细胞中增加GLP-1受体激动剂的表达，从而达到持久调节机体代谢功能的效果。该公司预计在2024年进行GLP-1 PGTx的毒理学和支持IND申请的临床前研究。 ◇CSL公司在ASH年会上公布了血友病B基因疗法Hemgenix的3年长期随访结果。在这项开放标签3期临床试验中，52名中重度血友病B患者完成了三年随访。Hemgenix在一年后产生的平均凝血因子IX水平为41.5 IU/dL，两年后因子IX平均水平为36.7 IU/dL，三年后平均水平为38.6 IU/dL。此外，94%接受治疗的患者无需持续接受预防性治疗。三年数据同时显示，在接受治疗后7-36个月期间，平均年化出血率（ABR）降低64%。 ◇Tome Biosciences公司宣布完成2.13亿美元的A轮和B轮融资。该公司致力于开发名为程序化基因组整合（PGI）的新技术，用于精确插入任何大小的DNA序列到目标基因组位置。 PGI技术结合了CRISPR/Cas9系统的位点特异性与不需切断DNA双链，就能够插入或写入DNA序列（包括完整基因）的酶。公司最先进的PGI技术称为整合酶介导的PGI（I-PGI），使用独特的整合酶。到目前为止，I-PGI已成功实现了在各种分裂和非分裂细胞类型中超过30 kb的遗传物质的精确位点特异性插入。它还提供了多重编辑的潜力，可进行复杂的细胞工程化改造，为细胞疗法开发的未来铺平了道路。 ◇Shinobi Therapeutics宣布完成5100万美元的A轮融资。该公司独特的方法基于共同科学创始人Tobias Deuse博士和Shin Kaneko博士的研究，首先编辑诱导多能干细胞（iPSCs）使其具有高度免疫逃逸能力，然后利用公司的专有技术将其分化为CD8αβ iPS-T细胞。这一技术平台有望让同种异体细胞疗法逃避免疫系统的排斥，降低细胞疗法的生产成本并提高疗法的可及性。除了上述动态，本周细胞和基因疗法领域还有一些其它进展，限于篇幅，本文不再一一介绍。希望该领域迎来更多的新进展和突破，惠及更多患者。参考资料： [1] Immusoft Administers the First Engineered B Cell in a Human Clinical Trial. Retrieved December 15, 2023, from https://www.businesswire.com/news/home/20231215132846/en [2] Precision BioSciences Announces Approval of First Clinical Trial Application of ARCUS Gene Insertion Program by Partner iECURE. Retrieved December 15, 2023, from https://www.businesswire.com/news/home/20231212100358/en [3] Ocugen, Inc. Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410—Modifier Gene Therapy—for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. Retrieved December 15, 2023, from https://www.globenewswire.com/news-release/2023/12/13/2795480/0/en/Ocugen-Inc-Announces-First-Patient-Dosed-in-Phase-1-2-Clinical-Trial-Evaluating-the-Safety-and-Efficacy-of-OCU410-Modifier-Gene-Therapy-for-Geographic-Atrophy-Secondary-to-Dry-Age-.html [4] Tome Biosciences Launches with Over $200 Million in Funding to Advance Programmable Genomic Integration Platform. Retrieved December 15, 2023, from https://www.globenewswire.com/news-release/2023/12/12/2794660/0/en/Tome-Biosciences-Launches-with-Over-200-Million-in-Funding-to-Advance-Programmable-Genomic-Integration-Platform.html [5] CSL Behring's HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates at Three Years Post-Treatment Long-Term Durability, Safety and Greater Bleed Protection Versus Prophylactic Treatment in People Living with Hemophilia B. Retrieved December 15, 2023, from https://www.prnewswire.com/news-releases/csl-behrings-hemgenix-etranacogene-dezaparvovec-drlb-demonstrates-at-three-years-post-treatment-long-term-durability-safety-and-greater-bleed-protection-versus-prophylactic-treatment-in-people-living-with-hemophilia-b-302011606.html [6] Fractyl Health Demonstrated That a Single Dose of a GLP-1-Based Pancreatic Gene Therapy Candidate (GLP-1 PGTx) Durably Maintained Weight Loss After Semaglutide Withdrawal in a Murine Model of Obesity at WCIRDC 2023 Annual Meeting. Retrieved December 15, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793883/0/en/Fractyl-Health-Demonstrated-That-a-Single-Dose-of-a-GLP-1-Based-Pancreatic-Gene-Therapy-Candidate-GLP-1-PGTx-Durably-Maintained-Weight-Loss-After-Semaglutide-Withdrawal-in-a-Murine.html [7] Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 15, 2023, from https://www.prnewswire.com/news-releases/poseida-therapeutics-presents-positive-early-results-from-its-phase-1-trial-of-allogeneic-car-t-p-bcma-allo1-in-relapsed-refractory-multiple-myeloma-at-the-65th-american-society-of-hematology-ash-annual-meeting-302010725.html [8] Long-term Follow-up Data From bluebird’s Gene Therapy Program in Sickle Cell Disease Support Durable, Potentially Curative Benefits Through Stable Production of Anti-Sickling Adult Hemoglobin and Resolution of Vaso-Occlusive Events. Retrieved December 15, 2023, from https://www.businesswire.com/news/home/20231209650405/en [9] First In Vivo CAR-M Lead Candidate Nominated Under Carisma-Moderna Collaboration. Retrieved December 15, 2023, from https://www.prnewswire.com/news-releases/first-in-vivo-car-m-lead-candidate-nominated-under-carisma-moderna-collaboration-302014783.html [10] Shinobi Therapeutics Launches with Completion of $51M Series A to Advance Hypoimmune iPS-T Cell Therapy Platform. Retrieved December 15, 2023, from https://www.prnewswire.com/news-releases/shinobi-therapeutics-launches-with-completion-of-51m-series-a-to-advance-hypoimmune-ips-t-cell-therapy-platform-302012188.html [11] Obsidian Therapeutics Announces Positive Interim Top-Line Clinical Data for OBX-115 Engineered TIL Cell Therapy in Advanced or Metastatic Melanoma Post-Anti-PD1 Therapy. Retrieved December 15, 2023, from https://www.businesswire.com/news/home/20231212231588/en [12] Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023. Retrieved December 15, 2023, from https://www.globenewswire.com/news-release/2023/12/12/2794331/0/en/Gracell-Biotechnologies-Presents-Updated-Clinical-Data-from-FasTCAR-T-GC012F-Demonstrating-Deep-and-Durable-Responses-in-Newly-Diagnosed-Multiple-Myeloma-at-ASH-2023.html [13] Nexcella Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023. Retrieved December 15, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793986/0/en/Nexcella-Announces-100-Overall-Response-Rate-n-10-23-7-months-Best-Response-Duration-ongoing-for-CAR-T-NXC-201-in-Relapsed-Refractory-AL-Amyloidosis-Patients-at-ASH-2023.html [14] Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs). Retrieved December 15, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793672/0/en/Affimed-Announces-Updated-Phase-1-2-Data-from-Acimtamig-in-Combination-with-Allogeneic-NK-in-Hodgkin-Lymphoma-Patients-Who-Failed-Prior-Chemotherapy-and-Are-Double-Refractory-to-Br.html 内容来源于网络，如有侵权，请联系删除。

细胞疗法免疫疗法基因疗法

2023-11-01

·PRNewswire

Curocell Completes Korea's First Phase 2 Clinical Trial for Next-Generation CAR-T

Anbal-cel argeting DLBCL completes phase 2 trial Anticipation growing over Korea's first CAR-T therapy ahead of regulatory review Commercial manufacturing scheduled in 2025 at Korea's only CAR-T GMP facility DAEJEON, South Korea, Nov. 1, 2023 /PRNewswire/ -- Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy "Anbal-cel" that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma). This announcement is a significant milestone and is paving the way towards the launch and approval of Korea's first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea. The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of "Anbal-cel" in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital. "Anbal-cel" is a next-generation CAR-T therapy based on Curocell's OVIS™ technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis. Curocell made international headlines during the company's oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial. The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market. Curocell plans to officially announce the final results of its Phase 2 clinical trial for "Anbal-cel" in the first half of next year and submit an BLA application to Korea's Ministry of Food and Drug Safety for approval next September. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea's only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment. CEO of Curocell, Gunsoo Kim said that, "I am extremely proud that we were able to complete Korea's first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea." He added, "We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business." The clinical trial for "Anbal-cel" was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. (Project Number: HN21C0653) Corporate Overview "Fight Against Hopelessness: Curocell is spearheading the development of innovative cancer immunotherapies" Curocell is Korea's first company specialized in CAR-T treatment, developing CAR-T cell therapies that have become one of the world's most promising new drugs to emerge in recent years. Curocell's technology aims to overcome the limitations of existing cancer immunotherapies to treat a wide variety of different cancer types. Curocell is working with top experts in various fields such as CAR-T technology development, biopharmaceutical development, production and GMP, while also collaboaring with major Korean hospitals for the systematic development of new CAR-T cell therapies. Curocell is Korea's first company to obtain regulatory approval to conduct CAR-T clinical trials, and is widely recognized as the country's leading company in the field of CAR-T cell therapy, possessing a large-scale commercial GMP facility with state-of-the-art equipment to manufacture its products. "CAR-T cell therapy, a next generation cancer immunotherapy" CAR-T (Chimeric Antigen Receptor-T) cell therapy is a next generation cancer immunotherapy that involves genetically modifying a patient's immune T cells in vitro to express antigens that specifically target cancer cells, then reintroducing them into the patient to destroy the cancer. Through the process of separating the patient's immune cells, modifying their genes, and cultivating them en masse, it is possible to achieve complete remission in a terminal leukemia patient with just a single administration where no other treatment options are available. SOURCE Crucocell Inc.

临床2期免疫疗法临床结果细胞疗法临床申请

2022-06-13

·PRNewswire

Curocell announced impressive CR rate in Phase 1 study with anbal-cel, the next generation CD19 CAR-T integrated OVIS™ platform

- 82% ORR (9 of 11 patients) and 82% (9 of 11 patients) CR rate documented after anbal-cel treatment to the patients in relapsed/refractory large B-cell lymphoma - 2 out of 3 patients dosed with 2x105 cells/kg of anbal-cel lasting the complete response for more than 12 months - Well tolerated up to 2X106 cells/kg dose level without DLT and not reached to MTD in Phase 1 dose escalation study DAEJEON, South Korea, June 13, 2022 /PRNewswire/ -- Curocell, Inc., a leading CAR-T company based in South Korea, announced the phase 1 dose-escalation study results documenting an 82% complete remission (CR) rate after a single dose of anbalcabtagene autoleucel (anbal-cel) to relapsed/refractory large B-cell lymphoma patients. Three (3) among 4 patients dosed at 2x105 cells/kg of anbal-cel documented complete remission, and 2 responding patients are maintaining the complete remission for more than a year. Strikingly, all patients dosed with 2x106 cells/kg reported complete remission after a single dose of anbal-cel. The complete phase 1 study results were presented at EHA at EHA (European Hematology Association) congress, Vienna, Austria, Jun 09-17, 2022. The anbal-cel is the CD19 CAR-T integrated with the OVISTM (Overcome Immune Suppression) platform. OVISTM technology consists of a dual knockdown system for two crucial immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells. "Although CD19 directed CAR-T therapy changed the treatment paradigm for Large B-cell lymphoma, which is one of the most aggressive hematologic malignant cancer, more than 50% of LBCL patients didn't experience the clinical benefit of CD19 CAR-T treatment, and there are still huge unmet medical needs. Anbal-cel's phase 1 study result demonstrates the OVISTM platform's potential to maximize CAR-T's functionality to eradicate tumors. We are very excited about this promising clinical result even though the patient number treated with anbal-cel is limited with a total of 11 and looking forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Furthermore, we believe these data represent the excellence of our next-generation CAR-T technology." said Gunsoo Kim, Curocell's chief executive officer. This phase 1 study was to evaluate the safety and preliminary efficacy in patients with r/rLBCL. Patient was infused as a single intravenous dose with 2x105 cells/kg (Dose Level 1), 7x105 cells/kg (DL2) or 2x106 cells/kg (DL3). Lymphodepletion with cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) was performed for 3 days prior to anbal-cel infusion. Eleven (11) patients with r/r DLBCL were infused with anbal-cel. All patients received two or more prior lines of therapy, and 36% (4/11) received ≥4 prior lines of treatment before the study. No patient experienced DLT during the study. Of the 11 patients, 5 (46%) patients experienced CRS; 3 (27%) were grade 1 or 2 and 2 (18%) experienced grade 3 CRS. The median time to onset of CRS was 7 days (range, 1-16) with a median duration of 5 days (range, 1-19). One patient dosed with 2x106 cells/kg experienced grade 2 ICANS; the time to onset of ICANS was 7 days and lasted for 13 days. This patient had prior CNS involvement history before the study. The frequently reported grade 3/4 treatment related AEs were anemia (2/11, 18%), neutropenia (2/11, 18%), thrombocytopenia (2/11, 18%), CRS (2/11, 18%). Dose-dependent CRC01 expansion was observed; median Tmax was 15.4, 15.8 and 14.5 days at DL1, DL2 & DL3 each; Cmax, AUC0-28 day was dose proportionally increased. Based on promising safety and efficacy data from Phase 1 study, Phase 2 trial has been commenced, and patient enrollment is ongoing. Details of the oral presentation at EHA are as follows: Submission ID: EHA-3438 Title: PHASE 1/2 STUDY OF ANBAL-CEL, NOVEL ANTI-CD19 CAR-T THERAPY WITH DUAL SILENCING OF PD-1 AND TIGIT IN RELAPSED OR REFRACTORY LARGE B CELL LYMPHOMA Session Title: Aggressive Lymphoma - CART Session date and time: Saturday, June 11 11:30 - 12:45 Session room: Hall A7 Final Abstract Code: S214 About anbalcabtagene autoleucel (anbal-cel) Anbal-cel, recognized CD19 and is based on OVISTM, a first-in-class CAR-T platform. OVISTM technology downregulates PD1 and TIGIT expression in CAR-T cells. Through overcoming the immune suppression by PD-L1 and TIGIT ligands, OVISTM CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. The Phase 2 clinical trial of anbal-cel has initiated in South Korea in the first half of 2022. About Curocell, Inc. Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVISTM technology intending to improve the clinical efficacy of CAR-T therapies. For more information, visit . SOURCE Curocell, Inc.

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适应症	最高研发状态	国家/地区	公司	日期
滤泡性淋巴瘤	临床2期	韩国	Curocell, Inc.	2021-03-02
高级别B细胞淋巴瘤	临床2期	韩国	Curocell, Inc.	2021-03-02
纵隔大b细胞淋巴瘤	临床2期	韩国	Curocell, Inc.	2021-03-02

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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


ESMO2023	临床2期	Carney复合症	-	Anbal-cel	繭艱糧網襯選獵窪鑰餘(淵艱繭鏇糧衊構簾餘壓) = 築鹹獵範網憲獵淵膚齋積遞襯蓋窪網選憲餘窪 (襯衊簾鬱淵衊構繭醖積 )	-	2023-10-23
ICML2023	N/A	大B细胞淋巴瘤	-	Anbal-cel	遞夢繭願遞鹽憲範齋壓(鹽觸蓋鏇廠鹹構網繭獵) = Responder group (CR) reported higher incidence and severity of CRS compared to non-responder group (Non-CR), but it was insignificant. 鹹構獵憲艱憲築築網網 (廠壓窪糧餘艱網構繭醖 ) 更多	-	2023-06-09
NCT04836507 (ESMO_ASIA2022) 人工标引	临床1/2期	弥漫性大B细胞淋巴瘤	11	CRC-01	襯鑰觸獵衊積窪憲網網(網鹽顧鬱選鬱淵製構鹹) = Anemia 22%, neutropenia 82%, thrombocytopenia 55% 憲蓋艱簾艱壓淵鏇構鹹 (鑰網衊窪獵襯簾積選築 )	积极	2022-12-04
NCT04836507 (ASCO2022) 人工标引	临床1/2期	B细胞淋巴瘤	9	CRC-01	遞淵積製遞壓鏇積蓋廠(鑰鹹廠醖衊憲餘鬱窪網) = 遞壓觸遞鏇網觸齋構網願製齋鹽憲簾製襯獵繭 (餘鏇鑰網衊膚簾憲積網 ) 更多	积极	2022-06-02