Prizloncabtagene autoleucel

//  • 西比曼C-CAR039的4年长期随访数据与强生JNJ-90014496全球Ib期研究结果，揭示双靶点CAR-T疗法在治疗复发/难治性大B细胞淋巴瘤的突破；• C-CAR039/JNJ-90014496有望重新定义R/R LBCL的治疗标准；• 细胞治疗的中美BD合作模式，为中国创新药企业的国际化发展开辟新路径。“我们的研究首次揭示了双靶点CD19/CD20的CAR-T疗法C-CAR039，在复发/难治性（R/R）大B细胞淋巴瘤（LBCL）患者中的长期生存获益。”西比曼生物科技集团（以下简称西比曼）董事长兼首席执行官刘必佐先生对研发客说。在EHA（欧洲血液学协会）2025会议上，西比曼公布了48例患者长达4年输注C-CAR039的随访数据，其中，所有患者高达91.5%的总体缓解率（ORR）、85.1%的完全缓解率（CRR），展现出其在长期生存获益方面的潜力。与此同时，作为西比曼全球合作伙伴的强生，也在EHA会议上公布了这款靶向CD19/CD20  CAR-T疗法（在强生的产品代号：JNJ-90014496）治疗R/R LBCL全球Ⅰb期的研究结果：在全部可评估患者中的ORR达90.5%，CRR为76.2%。2023年5月，强生旗下的杨森公司与西比曼达成了这款靶向CD19/CD20 CAR-T疗法的全球独家合作。“抗原逃逸是B细胞恶性肿瘤常见的耐药机制，” 刘必佐向研发客表示，“C-CAR039是通过同时靶向CD20和CD19抗原，来提高治疗效果并降低抗原逃逸的可能性。”R/R LBCL是非霍奇金淋巴瘤（NHL）中治疗难度较大的亚型，其中，弥漫性大B细胞淋巴瘤（DLBCL）占所有NHL病例的30%~40%，且该类患者约有30%~40%在一线R-CHOP方案治疗后复发或进展为难治性，传统治疗方法患者预后不佳。目前在临床上，CD19 CAR-T细胞疗法已彻底改变R/R LBCL的治疗模式，三线及以上治疗的CRR可达58%。但因抗原逃逸而复发的临床治疗需求，仍未得到满足。此次C-CAR039/JNJ-90014496双维度临床数据的公布，将为R/R LBCL患者的治疗带来全新希望。4年保持良好的疗效和安全性C-CAR039的中国Ⅰ期试验显示，其在R/R LBCL患者中实现86%的CRR。4年长期随访数据更展示出积极的结果。疗效评估显示，该疗法在所有患者的ORR高达91.5%，其中，CRR达85.1%；在LBCL亚组中，ORR与CRR分别维持在90.7%和86.0%的高水平。安全性方面，细胞因子释放综合征（CRS）总体发生率为93.8%，但≥3级严重CRS事件仅占2.1%；免疫效应细胞相关神经毒性综合征（ICANS）发生率较低（6.3%），且未观察到≥3级病例。值得注意的是，长期随访期间未发现新的安全性信号，表明C-CAR039在长期应用中仍能维持良好的安全性特征。“这一疗法在R/R B-NHL治疗中展现出了优异的疗效与持久安全性，验证了来自西比曼自主研发CAR-T产品的技术优势，并有望成为R/R LBCL患者的标准治疗方案之一。”刘必佐先生说。全球Ⅰb期研究再次验证疗效这款双靶点CAR-T疗法在强生的助力下，在全球28个国家，与美国、英国、澳大利亚、韩国等知名研究机构开展了Ⅰb期研究。JNJ-90014496的Ⅰb期研究显示，在LBCL疗效方面，全剂量组42例可评估患者中， ORR达90.5%，CRR为76.2%。在安全性方面，RP2D剂量组未观察到3/4级CRS，仅5%的患者出现1级ICANS，整体治疗相关不良事件（TEAE）发生率为77%，但未出现治疗相关死亡病例，体现了良好的安全性与耐受性。刘必佐先生表示：“强生JNJ-90014496全球Ⅰb期试验结果，再次证明了双靶点CD19/CD20 CAR-T疗法在R/R LBCL上的突破性疗效。”双靶点设计克服抗原逃逸C-CAR039是由西比曼自主研发的CAR-T产品，其核心优势在于双靶点设计，而双靶点设计是技术突破的关键。传统CD19 CAR-T疗法虽在R/R LBCL中取得疗效（CRR约58%），但抗原逃逸导致的复发仍是主要挑战。C-CAR039通过同时靶向CD19和CD20抗原，实现了更深的组织穿透性。据西比曼介绍，双靶点结合可增强CAR-T细胞对肿瘤细胞的识别与杀伤能力，更彻底地清除B细胞，降低抗原逃逸风险，延长缓解持续时间；优化后的CAR结构减少了非特异性激活，提升了安全性。在2021年ASCO上西比曼发布了C-CAR039初步临床数据，立即引起了高度关注，此后不久杨森就与西比曼达成C-CAR039（CD19/CD20双靶点）和C-CAR066（CD20单靶点）的合作，杨森支付2.45亿美元预付款，并承诺支付开发、监管和销售里程碑的后续付款及销售分成。2023年12月，双方修订协议，杨森获得C-CAR039和C-CAR066在中国市场的商业化权利；西比曼保留C-CAR039在中国市场的权益，同时通过技术授权实现全球价值最大化。西比曼与强生的合作模式，为全球细胞治疗提供了成功范例。除R/R LBCL外，C-CAR039在滤泡性淋巴瘤、套细胞淋巴瘤等适应症中的研究正在推进。“通过与强生这样的国际巨头合作，使得中国的创新药临床和商业价值最大化，这具有重要意义。除了能带来资金和技术，更重要的是在交易后，还能与国际巨头在MRCT、生产、供应链上继续合作、相互学习，为中国创新药走向世界提供了经验，令产品快速进入全球市场，最终让我们的新药惠及全球患者，为他们带来新的希望。”刘必佐说。编辑 | 姚嘉yao.jia@PharmaDJ.com总第2471期访问研发客网站，深度报道和每日新闻抢鲜看www.PharmaDJ.com

MILAN, Italy I June 16, 2025 I AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented promising four-year clinical outcomes from 48 relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients treated with C-CAR039 (also known as Prizloncabtagene Autoleucel) in greater China, at the European Hematology Association (EHA) 2025 Congress. The study evaluated the safety and efficacy of C-CAR039, a novel anti-CD19/CD20 bi-specific CAR-T therapy. The dual-targeting approach to both CD20 and CD19 antigens aims to enhance therapeutic efficacy and reduce the likelihood of antigen escape, a common mechanism of resistance in B-cell malignancies. Key Findings: Safety Highlights: C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients, especially in those with R/R LBCL. These results continue to provide strong support for the curative potential of C-CAR039 as a next-generation therapy for R/R B-NHL. Late-stage clinical development is ongoing. “The long-term clinical outcomes data for C-CAR039 are highly encouraging, demonstrating sustained responses in patients with relapsed or refractory B-cell non-Hodgkin lymphoma,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. “These results underscore our commitment and corporate goal to develop transformative therapies that address significant unmet medical needs in cancer.” Dr. Yihong Yao, Chief Scientific Officer of AbelZeta, commented, “The strong clinical results of C-CAR039 demonstrate the added value of targeting CD20 in addition to CD19 in aggressive B-NHL. By addressing the limitations of single-antigen therapies – such as CD19 antigen escape – C-CAR039 enables deeper tissue penetration and more complete B-cell depletion. The durable responses observed support the continued advancement of C-CAR039 as a promising new treatment for patients with aggressive B-cell malignancies.” For more information on the study and access to the poster presentation, please visit the EHA Library poster here . AbelZeta previously presented 30-month Phase 1 clinical trial results at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023, through oral presentation #1025 , as well as at EHA 2024, through poster presentation #P1475 . The data with 30 months follow up was published in Blood 2025 Apr 3;145(14):1526-1535 . AbelZeta Inc. (formerly known as Cellular Biomedicine Group, Inc.), entered into a worldwide collaboration and licensing agreement with Johnson & Johnson* in 2023 to develop and commercialize next-generation CAR-T cell therapies (excluding Greater China). The Phase 1 study for C-CAR039 was conducted by AbelZeta in China for the treatment of patients with B-cell non-Hodgkin lymphoma. Johnson & Johnson is evaluating the safety and efficacy of this asset (known as JNJ-90014496 outside of Greater China) through a separate study involving a global patient population. Phase 1b data for JNJ-90014496 were presented at EHA 2025 on Friday, June 13, informing the recommended Phase 2 dose and an initial assessment of safety, efficacy and pharmacokinetics in R/R LBCL patients. For more information, please visit Johnson and Johnson website: https://www.jnj.com/media-center/press-releases/johnson-johnsons-dual-targeting-car-t-cell-therapy-shows-encouraging-first-results-in-large-b-cell-lymphoma . *The legal entity to the worldwide collaboration and license agreement is Janssen Biotech, Inc., a Johnson & Johnson company. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies. SOURCE: AbelZeta Pharma