临床试验中 2304 例接受 CD19 CAR-T 治疗的大 B 细胞淋巴瘤应答的种族与临床决定因素

Chimeric antigen receptor T-cell (CAR T) therapy has advanced treatment for B-cell lymphoma (BCL), but >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 2304 patients with BCL. The nature of this data set, 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 2304 patients, 395 (17. 1%) failed screening, and 1637 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 2 cohorts: large BCL (LBCL, n = 958) and indolent BCL (iBCL, n = 349).

Multivariate Cox models revealed that low performance status and high tumor burden (Eastern Cooperative Oncology Group 2, bulky disease, bridging therapy) negatively affected overall survival (OS) and progression-free survival (PFS) in LBCL, whereas age and shorter time from diagnosis to infusion negatively impacted OS and PFS in iBCL. Despite the underrepresentation of non-White groups across all trial phases, the feasibility and effectiveness of CAR T therapy were consistent across racial and ethnic groups.