接受 BCMA/CD19 CAR-T 细胞治疗的复发/难治性多发性骨髓瘤患者中延长的血液学毒性

UNLABELLED: Although chimeric antigen receptor T (CAR-T) cell therapy has been indicated to be effective in treating relapsed or refractory multiple myeloma (R/R MM), severe hematological toxicity (HT) remains an intractable issue.

This study enrolled 54 patients with R/R MM following combined infusion of anti-CD19 and anti-BCMA CAR-T cells. The results showed that the rates of severe cytopenia were high, including severe neutropenia (28/54, 52%), severe anemia (15/54, 28%), and severe thrombocytopenia (18/54, 33%).

Moreover, the incidence of prolonged HT (PHT) on Day 28 post-infusion was 52% (28/54), including 46% for severe neutropenia, 30% for severe anemia, and 31% for severe thrombocytopenia. Patients with PHT had a poorer median progression-free survival (PFS) and overall survival (OS) than patients without PHT ( P =0. 011; P =0. 007).

Furthermore, Cox regression analyses showed that PHT was an independent risk factor for PFS and OS. Univariate analyses showed that IFN (OR: 1. 046; 95% CI: 1. 002-1. 093, P =0. 042) and severe HT after lymphodepletion chemotherapy (OR: 0. 082; 95% CI: 0. 017-0. 404; P =0. 002) were independent risk factors for PHT.

In conclusion, these results indicated that PHT was associated with poor outcomes following CAR-T-cell therapy in MM patients. Early detection and management of PHT would be beneficial for the prevention of life-threatening complications and improvement in the survival of patients after CAR-T-cell therapy. CLINICAL TRIAL REGISTRATION: This trial was registered on 1 May 2017 at http://www. chictr. org. cn as ChiCTR-OIC-17011272.