Phase 1 BAFFR-CAR T (BAFF-R–targeted CAR-T) in relapsed/refractory B-ALL/B-LL

City of Hope is running a Phase 1, first-in-human study of autologous BAFFR-targeting CAR T cells, an adoptive cell therapy where a patient’s own T cells are genetically engineered to recognize BAFF-R (BAFFR/TNFRSF13C) on malignant B-lineage blasts and then reinfused. The trial’s main goals are safety, dose-finding, and early efficacy signals, using leukapheresis, optional bridging therapy, lymphodepletion with cyclophosphamide (DNA-alkylating cytotoxic) plus fludarabine (purine analog that inhibits DNA synthesis), and then a single BAFFR-CAR T infusion. Eligible patients have relapsed/refractory B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma with BAFF-R expression and are ineligible for or have failed prior CD19-targeted therapy (e.g., blinatumomab or CD19 CAR T), addressing a key post-CD19 relapse setting. The commercial/scientific angle is antigen-switching to BAFF-R as an alternative B-lineage target to potentially recapture responses after CD19 escape; current care in this scenario often involves salvage multi-agent chemotherapy, inotuzumab ozogamicin or blinatumomab when feasible, CD22- or CD19-directed cellular therapy if eligible, and transplant in responders—yet outcomes remain poor after multiple relapses.