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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2025, Vol. 30 ›› Issue (11): 1578-1584.doi: 10.12092/j.issn.1009-2501.2025.11.016

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Discussion on the key points of clinical trials for FDA-approved CAR-T cell therapy products

PENG Siqi, HAN Jinghong   

  1. The Greater Bay Area Sub-Center for Drug Evaluation and Inspection of the National Medical Products Administration, Shenzhen 518000, Guangdong, China
  • Received:2025-06-20 Revised:2025-09-20 Online:2025-11-26 Published:2025-12-04

Abstract:

As a groundbreaking advancement in cancer immunotherapy, chimeric antigen receptor T-cell (CAR-T) therapy has revolutionized treatment options for patients with hematologic malignancies. Based on the Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products Guidance for Industry, this study systematically analyzes key clinical trial data from seven FDA-approved CAR-T products as of 2024. The analysis provides detailed discussion on several pivotal aspects including single-arm trial design and control settings, recommended dosing strategies, as well as safety and efficacy evaluation methodologies. While CAR-T therapy has demonstrated remarkable clinical success, future development directions encompass expansion into solid tumors, exploration of novel targets, advancement of universal CAR-T technologies, optimization of combination therapies, and integration of emerging technologies such as artificial intelligence, all of which will collectively drive the high-quality development of the CAR-T industry.

Key words: chimeric antigen receptor T-cell (CAR-T), cellular therapy, clinical trials, risk management

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