CT103A is a fully human chimeric antigen receptor T cell (CAR-T) product for targeting B cell maturation antigen. This study presents the updated safety and efficacy profiles of CT103A in patients with relapsed/refractory multiple myeloma (RRMM) after long-term follow-up. As of July 31, 2023, the median follow-up time after CAR-T cell infusion was 45.0 months (range, 0.7–58.3 months). During long-term follow-up, the incidence of adverse events gradually decreased over time. One patient had a maximum duration of response of nearly 5 years. All 18 patients (100%) achieved partial remission or better; 77.8% (14 of 18) of patients eventually exhibited complete response or stringent complete response (sCR), with response increasing over time. At the time of data cutoff, nine patients were still alive and seven patients had an sCR status with negative minimal residual disease. The median progression-free survival was 22.6 months, and the median overall survival was 50.2 months for all 18 patients. The median CAR transgene persistence was 14.0 months (range, 0.7–57.3 months). Long-term follow-up demonstrated that CT103A confers durable clinical benefit for RRMM patients based on the sustained presence of fully human CAR-T cells.

中文翻译：

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全人源 CAR-T 疗法 CT103A 在复发/难治性多发性骨髓瘤中的长期安全性和有效性


CT103A 是一种全人嵌合抗原受体 T 细胞 （CAR-T） 产品，用于靶向 B 细胞成熟抗原。本研究介绍了 CT103A 在长期随访后治疗复发/难治性多发性骨髓瘤 （RRMM） 患者的最新安全性和有效性概况。截至 2023 年 7 月 31 日，CAR-T 细胞输注后的中位随访时间为 45.0 个月（范围，0.7-58.3 个月）。在长期随访期间，不良事件的发生率随着时间的推移逐渐下降。1 例患者的最长缓解持续时间接近 5 年。所有 18 例患者 （100%） 均达到部分缓解或更好;77.8% （18 例中的 14 例） 的患者最终表现出完全缓解或严格完全缓解 （sCR），反应随着时间的推移而增加。在数据截止时，9 例患者仍然存活，7 例患者具有 sCR 状态且微小残留病阴性。所有 18 例患者的中位无进展生存期为 22.6 个月，中位总生存期为 50.2 个月。CAR 转基因持久性中位为 14.0 个月 （范围，0.7-57.3 个月）。长期随访表明，基于全人 CAR-T 细胞的持续存在，CT103A 为 RRMM 患者带来持久的临床益处。