Trials of CAR T-Cell Therapies Lacking Black Participants

Enrollment of Black participants in the clinical trials that resulted in US Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapies was suboptimal, according to a recent cross-sectional study.

Researchers looked at data from seven clinical trials including 1,057 patients with large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, acute lymphocytic leukemia (ALL), and multiple myeloma (MM). Trials took place between August 2017 and May 2021 and investigated various CAR T-cell products.

Of the included patients, 71% received the CAR T-cell products, and efficacy was reported in 69%.
The researchers noted that Black participants were included in the racial category “other” in the study supporting tisagenlecleucel approval in ALL; otherwise, enrollment was specified at study publication and/or in the demographic subgroup information available through the FDA.

The number of Black participants that received CAR T-cell therapy ranged from 2% to 5%. The total number of Black participants enrolled with CAR-T efficacy reported per disease category was 18 for diffuse large B-cell lymphoma, and only (6%) for MM.

“The findings of this study suggest that low enrollment of Black persons exists in trials for CAR-T therapy and that the disparity is substantial and ongoing, especially for therapies to treat [MM],” study researchers wrote. “Efforts should be made to understand and overcome barriers that lead to decreased enrollment of Black participants in clinical trials that include novel, potentially beneficial, and/or curative CAR-T therapies in difficult-to-treat hematological malignant neoplasms with otherwise limited treatment options.”

Al Hadidi S, Schinke C, Thanendrarajan S, et al. Enrollment of Black participants in pivotal clinical trials supporting US Food and Drug Administration approval of chimeric antigen receptor-T cell therapy for hematological malignant neoplasms. JAMA Network Open. 2022;5(4):e228161.