A global multidimensional analysis of the chimeric antigen receptor T-cell therapy clinical trial landscape and development trends

Chimeric antigen receptor T-cell (CAR-T) therapy has advanced significantly in oncology. To reveal the main trends affecting this field, we collected trial information of 1,908 CAR-T clinical trials using the INFORMA database. Since 2010, the number of CAR-T trials has increased sharply. China (1,006 trials) and the United States (549 trials) accounted for over 80% of all studies. Only 4.2% were sex-restricted studies and only 22% involved children. Although most studies were early phase, the number of phase III/IV trials has been steadily increasing. Research has predominantly focused on hematologic malignancies, including non-Hodgkin lymphoma, acute lymphoblastic leukemia, and multiple myeloma. While progress in solid tumors has been comparatively slower, it is steadily advancing. In addition, CAR-T therapy has demonstrated potential in treating certain autoimmune diseases. While CD19 molecule and TNF receptor superfamily member 17 remain dominant targets, other targets-including mesothelin and claudin 18 for solid tumors-were increasingly investigated. Several approved CAR-T products, such as Axicabtagene ciloleucel and Tisagenlecleucel, have undergone numerous clinical trials, resulting in expanded indications and refined treatment strategies. These findings offer some valuable insights into the status and prospects of CAR-T clinical trials.