Abstract
Safety and efficacy of allogeneic anti-CD19 chimeric antigen receptor T cells (CAR-T cells) in persons with CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) relapsing after an allotransplant remain unclear. Forty-three subjects with B-ALL relapsing post allotransplant received CAR-T cells were analyzed. 34 (79%; 95% confidence interval [CI]: 66, 92%) achieved complete histological remission (CR). Cytokine release syndrome (CRS) occurred in 38 (88%; 78, 98%) and was ≥grade-3 in 7. Two subjects died from multiorgan failure and CRS. Nine subjects (21%; 8, 34%) developed ≤grade-2 immune effector cell-associated neurotoxicity syndrome (ICANS). Two subjects developed ≤grade-2 acute graft-versus-host disease (GvHD). 1-year event-free survival (EFS) and survival was 43% (25, 62%). In 32 subjects with a complete histological remission without a second transplant, 1-year cumulative incidence of relapse was 41% (25, 62%) and 1-year EFS and survival, 59% (37, 81%). Therapy of B-ALL subjects relapsing post transplant with donor-derived CAR-T cells is safe and effective but associated with a high rate of CRS. Outcomes seem comparable to those achieved with alternative therapies but data from a randomized trial are lacking.
Highlights
Persons experiencing B-cell acute lymphoblastic leukemia (B-ALL) relapse after an allogeneic hematopoietic cell transplant are typically treated by stopping immune10 Department of Otolaryngology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA11 Haematology Research Centre, Department of Immunology and Inflammation, Imperial College London, London, UK suppression, receiving a donor lymphocyte infusion (DLI) and/or receiving a second transplant from the same or a different donor
Allogeneic anti-CD19 chimeric antigen receptors (CARs)-T cells receive activation signals from T-cell receptors (TCRs) to target cell alloantigens and from CD19 on leukemia cells. This dual signaling may increase the antileukemia efficacy compared with autologous CAR-T cells
Our data indicate that donor-derived anti-CD19 CAR-T cells are a safe and effective therapy for B-ALL recurrence after allotransplantation
Summary
11 Haematology Research Centre, Department of Immunology and Inflammation, Imperial College London, London, UK suppression, receiving a donor lymphocyte infusion (DLI) and/or receiving a second transplant from the same or a different donor. The outcomes of these interventions are unsatisfactory [1,2,3]. Allogeneic anti-CD19 CAR-T cells receive activation signals from T-cell receptors (TCRs) to target cell alloantigens and from CD19 on leukemia cells. This dual signaling may increase the antileukemia efficacy compared with autologous CAR-T cells. The safety and efficacy of this approach are unknown
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