Racial and Clinical Determinants of Response in 2,304 r/r BCL Treated with Anti-CD19 CAR T-Cells in Clinical Trials Open Access

• This study pools data from 9 CAR T clinical trials, revealing key clinical and racial factors impacting outcomes in B-cell lymphoma.

• CAR T therapy showed consistent effectiveness across racial groups, with distinct prognostic factors identified for LBCL and iBCL.

Chimeric antigen receptor (CAR) T-cell therapy has advanced treatment for B-cell lymphoma (BCL), but more than 50% of patients relapse. Predicting clinical outcomes based on features at CAR T infusion remains unclear, and most trials lack racial diversity, limiting understanding of its impact on outcomes. To address these challenges, we pooled data from 9 CAR T clinical trials, consisting of 2,304 patients with BCL. The nature of this dataset, made available through the Medidata Clinical Cloud®, represents a large set of patient-level data aggregated over 9 clinical trials that has not been previously analyzed in this manner. Of the 2,304 patients, 395 (17.1%) failed screening, and 1,637 were assigned CAR T; 151 (9.22%) did not receive treatment due to adverse events, disease progression, or death, with only 12% surviving at 1 year. For treated patients, we analyzed two cohorts: large BCL (LBCL, n=958) and indolent BCL (iBCL, n=349). Multivariate Cox models revealed that low performance status and high tumor burden (ECOG ≥2, bulky disease, bridging therapy) negatively affected overall survival (OS) and progression-free survival (PFS) in LBCL, while age and shorter time from diagnosis to infusion negatively impacted OS and PFS in iBCL. Despite underrepresentation of non-white groups across all trial phases, the feasibility and effectiveness of CAR T-cell therapy were consistent across racial and ethnic groups.