异基因靶向 BCMA 的 CAR-T 细胞治疗复发/难治性多发性骨髓瘤：1 期 UNIVERSAL 试验中期结果

ALLO-715 is a first-in-class, allogeneic, anti-BCMA CAR T cell therapy engineered to abrogate graft-versus-host disease and minimize CAR T rejection.

We evaluated escalating doses of ALLO-715 after lymphodepletion with an anti-CD52 antibody (ALLO-647)-containing regimen in 43 patients with relapsed/refractory multiple myeloma as part A of the ongoing first-in-human phase 1 UNIVERSAL trial. Primary objectives included determination of the safety and tolerability of ALLO-715 and the safety profile of the ALLO-647-containing lymphodepletion regimen.

Key secondary endpoints were response rate and duration of response. Grade 3 adverse events were reported in 38 (88. 0%) of patients. Cytokine release syndrome was observed in 24 patients (55. 8%), with 1 grade 3 event (2. 3%) and neurotoxicity in 6 patients (14%), with no grade 3 events. Infections occurred in 23 patients (53. 5%), with 10 (23. 3%) of grade 3.

Overall, 24 patients (55. 8%) had a response. Among patients treated with 320 10 6 CAR + T cells and a fludarabine-, cyclophosphamide- and ALLO-647-based lymphodepletion regimen (n = 24), 17 (70. 8%) had a response including 11 (45. 8%) with very good partial response or better and 6 (25%) with a complete response/stringent complete response. The median duration of response was 8. 3 months. These initial results support the feasibility and safety of allogeneic CAR T cell therapy for myeloma.