Outcomes of locally produced donor-derived anti-CD19 chimeric antigen receptor T-cells in relapsed or refractory B-cell acute lymphoblastic leukemia patients.

Donor-derived anti-CD19 chimeric antigen receptor T-cell (CAR T-cell) therapy has emerged as one of the most promising treatments for relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). In this retrospective study, we evaluated the safety and efficacy of donor-derived anti-CD19 CAR T cells manufactured at our local GMP-compliant production facility. Eleven patients with R/R B-ALL received donor-derived anti-CD19 CAR T-cell therapy. Seven of the eleven patients had previously undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). All eleven patients achieved minimal residual disease (MRD) negativity by day 28 post-infusion. Three patients developed grade 1 cytokine release syndrome (CRS), and one patient developed grade 2 CRS. No case of immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. The patient who experienced grade 2 CRS also developed grade 2 graft-versus-host disease (GVHD. At the median follow-up time of 47 months (range, 6-104 months), eight patients remained alive and MRD-negative. Three patients died: one from bone marrow (BM) relapse, one from concurrent BM and central nervous system (CNS) relapses, and one from candidemia. The 5-year overall survival and event-free survival rates were both 70%. In this retrospective study, donor-derived anti-CD19 CAR T-cells produced in a GMP-compliant environment demonstrated a favorable safety profile and high efficacy in treating patients with R/R B-ALL. Larger studies are warranted to confirm these findings.