肿瘤细胞治疗研究
英文原题：Puzolcabtagene Autoleucel: Pediatric First Approval.
Puzolcabtagene Autoleucel: Pediatric First Approval.
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2025 年 11 月 4 日，puzolcabtagene autoleucel 在中国获得首次批准，用于治疗 3-21 岁患者的 CD19 + 复发/难治性（R/R）B-ALL。
普佐卡布他基因自体白细胞是一种自体、人源化抗CD19嵌合抗原受体（CAR）T细胞疗法，由重庆精准生物开发，用于治疗B细胞急性淋巴细胞白血病（B-ALL）、B细胞白血病和淋巴瘤，以及非霍奇金淋巴瘤。CAR-T 细胞疗法是一种个体化免疫疗法，通过对患者自身T细胞进行基因工程改造，使其通过直接细胞毒作用、诱导凋亡及TNF配体介导的信号通路识别并清除恶性细胞。为降低免疫原性，普佐卡布他基因自体白细胞采用人源化CD19特异性单链可变片段。2025年11月4日，该疗法首次在中国获批，用于治疗3–21岁CD19阳性复发/难治性B-ALL患者。本文总结促成其首次获批的关键研发里程碑。
Puzolcabtagene autoleucel [ ] is an autologous, humanized anti-CD19 chimeric antigen receptor (CAR) T-cell therapy developed by Chongqing Precision Biotech for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), B-cell leukemias and lymphomas, and non-Hodgkin lymphoma. CAR T-cell therapy is a personalized immunotherapy in which a patient's own T cells are genetically engineered to recognize and eliminate malignant cells through direct cytotoxicity, induction of apoptosis, and TNF ligand-mediated signaling pathways. To reduce immunogenicity, puzolcabtagene autoleucel incorporates a humanized CD19-specific single-chain variable fragment. On 4 November 2025, puzolcabtagene autoleucel received its first approval in China for the treatment of CD19 + relapsed or refractory (R/R) B-ALL in patients aged 3-21 years. This article summarizes the key developmental milestones leading to this first approval.
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