Analysis of Clinical Trial Registration Information for Chimeric Antigen Receptor T-cell Therapies in China from 2015 to 2022
10.3870/j.issn.1004-0781.2024.09.030
- VernacularTitle:2015-2022年我国嵌合抗原受体T细胞临床试验注册信息分析
- Author:
Yujie GU
1
;
Haiyan LI
;
Qian ZHAO
;
Wei XI
Author Information
1. 三峡大学第一临床医学院,宜昌 443000;三峡大学健康医学院,宜昌 443002
- Keywords:
Chimeric antigen receptor T-cell;
Immunotherapy;
Pharmaceutical clinical trials;
Information analysis
- From:
Herald of Medicine
2024;43(9):1524-1530
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the current situation and future trends of CAR-T related clinical trials in China and to provide references for CAR-T therapy development.Methods Retrieving all CAR-T related clinical project information registered in the ChiCTR and the Drug Clinical Trial Registration and Information Disclosure Platform of the NMPA.Employing a bibliometric approach to analyze the registered projects,including registration titles,registration dates,registration types,studied diseases,targets,clinical trial information for market application,and status of approved CAR-T therapies.This analysis aims to discern the characteristics and current state of domestic CAR-T clinical trials in China.Results 277 studies were registered in the center,with a significant concentration in Jiangsu,Shanghai,Guangdong,and Hubei provinces.Among these,there were 163 interventional studies and 114 observational studies,with only five studies involving sample sizes of over 100 participants.The primary source of funding is predominantly corporate sponsorship(50.5%);The primary indications are hematological malignancies,constituting 73.3%(203/277);In single-target studies,CD19 accounts for 43%(79/183),while BCMA represents 9%(17/183);There are 27 registered projects on the platform,encompassing 14 distinct varieties.Out of these,only two have achieved market authorization.The sponsoring entities for 26 out of the 27 projects are domestic enterprises;Phase I or II studies comprise a significant majority,accounting for 96%(26/27).China has introduced three approved CAR-T therapies to the market,with two of them originating from domestic enterprises.Conclusions Most CAR-T research in China is primarily concentrated in regions with well-developed medical resources and is predominantly led by domestic enterprises.This concentration is particularly pronounced in the treatment of hematological malignancies.Presently,most studies are still in the clinical trial phase.Given the relatively recent registration timeframe,it will take some time to transition from completing research to seeking market authorization.
