Clinical Outcomes of CD7 CAR-T Cell Therapy in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Patients.

Relapse and refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma (R/R T-ALL/LBL) patients have poor outcomes. Chimeric antigen receptor (CAR)-T-cell therapy for T-ALL/LBL has shown encouraging results in the early stages of clinical trials. Here, we retrospectively analyzed the outcomes of 12 patients with R/R T-ALL/LBL who received CD7 CAR-T cell therapy. Eleven patients received autologous CAR-T cells, while one patient received allogeneic CAR-T cells. On Day 28 post-infusion, 67% (8/12) of patients achieved an overall response (ORR). At a median follow-up of 134 (14-925) days, the median overall survival (OS) was 134 days, and the progression-free survival (PFS) was 81 days. Among the 8 patients who achieved remission after CD7 CAR-T cell infusion, 5 patients received consolidation allogeneic hematopoietic stem cell transplantation (allo-HSCT). Compared with 3 patients who did not undergo consolidation allo-HSCT, patients with allo-HSCT as consolidation showed a trend toward better OS (allo-HSCT vs. control: 6-month OS, 60% vs. 33.3%, p = 0.073) and better PFS (allo-HSCT vs. control: 6-month PFS, 60% vs. 0%, p = 0.022). Cytokine release syndrome (CRS) occurred in all patients (grade 1-2 in 67% of patients, grade 3 in 33% of patients), and one patient experienced neurotoxicity. CD7 CAR-T cell therapy is a promising option for R/R T-ALL/LBL patients with manageable adverse events. Moreover, CD7 CAR-T cell infusion followed by consolidation allo-HSCT in R/R T-ALL/LBL patients might play an important role in prolonging remission duration.