Current Progress of Cell Therapy Clinical Trials in China in 2014-2024.

Background: This paper summarizes the cell therapy clinical trials in China over the past decade to put forward suggestions for future clinical development in this field. Methods: Mainly based on the Centre for Drug Evaluation of China National Medical Products Administration (NMPA) website, a list and detailed information of cell therapy drugs in China were acquired. The annual number and basic characteristics including cell type, clinical trial phase, clinical trial status, geographical distribution, disease types, and drug target of registered drugs were summarized. Results: There have been 206 cell therapy trials between 2014 and 2024 in China. The top three cell types are T cells (51.4%, 106/206), stem cells (34.0%, 70/206), and progenitor cells (4.9%, 10/206), respectively. In terms of the phase distribution, 64.1% (132/206) were Phase I, 32.5% (67/206) were Phase II, and 3.4% (7/206) were Phase III. Currently, 86.4% (178/206) of cell therapy trials are open, 9.7% (20/206) have been completed, and the remainder are either suspended or terminated. Geographical analysis showed that 31.6% (65/206) of trials were conducted in Shanghai, 20.4% (42/206) in Beijing, and 9.2% (19/206) in Jiangsu. Twenty-eight disease types were identified, of which lymphoma (15.5%, 32/206) was the top disease type, followed by leukemia (12.6%, 26/206) and inflammation (9.2%, 19/206). The three most common targets were CD19 (54.9%, 39/71), BCMA (9.9%, 7/71), and EGFR (5.6%, 4/71). Conclusions: Cell therapy clinical trials in China have developed rapidly in the past decade. Perhaps in the future, the direction worthy of attention could include increasing funding for Phase III clinical trials, supporting a more balanced geographical distribution of trials, and more investment in target development. With the continuous progress of technology, cell therapy is expected to become an important means to treat various diseases.