Prizloncabtagene autoleucel

西比曼生物靶向CD20/CD19的双特异性CAR-T疗法C-CAR039（普龙基奥伦赛）从强生回归后，快速自行申报美国FDA，自主在美国开展临床试验。 基于此前在欧洲和中国良好的数据，FDA也立刻许可其IND，并在美国开展用于治疗复发或难治性（r/r）大B细胞淋巴瘤（LBCL）的临床试验。 “我们非常欣喜C-CAR039回归我们的血液恶性肿瘤管线，”西比曼生物董事长兼首席执行官刘必佐先生表示。 C-CAR039曾于2023年5月授权给强生（主要针对中国以外地区开发），同年12月协议进一步扩大至包含中国权益。2026年4月30日，强生终止C-CAR039项目。最终在2026年7月，西比曼重新收回了C-CAR039的全部开发、商业化等全球权益。此次回归，标志着西比曼已完全掌握该管线的全球自主权。 拓展阅读： 跨国公司“进退”之间，CAR-T赛道迎下半场 目前，西比曼正与FDA沟通，确定针对既往接受过CAR-T疗法治疗的三线或以上LBCL患者，以及既往未接受过CAR-T疗法治疗的二线LBCL患者的临床开发方案。 刘必佐说：“迄今为止的临床试验结果表明，C-CAR039在复发或难治性LBCL患者中表现出良好的安全性和令人鼓舞的疗效。该药有望帮助那些曾接受过已获批CAR-T疗法治疗后复发的患者。我们还将探索C-CAR039在LBCL更早线治疗中的潜力。” 在中国，C-CAR039的关键性II期临床试验仍在进行中，针对既往未接受过CAR-T疗法治疗的复发或难治性LBCL患者。 该疗法的积极长期临床数据曾于2026年3月在欧洲血液与骨髓移植学会（EBMT）会议上公布。在中国开展的早期临床试验中，48例复发或难治性B细胞非霍奇金淋巴瘤（B-NHL）患者的结果显示，该疗法具有良好的安全性，并实现了深度且持久的缓解。具体数据为：总缓解率（ORR）达91.5%，完全缓解（CR）率为85.1%，中位随访时间为53.9个月，中位无进展生存期（PFS）为60.1个月。 总第3083期 访问研发客网站www.PharmaDJ.com 深度报道和每日新闻抢鲜看

ROCKVILLE, Md. and SHANGHAI, Aug. 16, 2026 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL). In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve. The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company's early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%. Median PFS was 60.1 months at a median follow-up of 53.9 months. "We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy." The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai. 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, inflammatory and immunological diseases and solid tumors. AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of AbelZeta Pharma, Inc.'s ("AbelZeta" or the "Company") control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. +1 (240) 552 5870 [email protected] SOURCE AbelZeta Pharma, Inc. 21% more press release views with Request a Demo