Phase I Daratumumab (CD38) Immunotherapy in High-Risk T-ALL/T-LLy

New York Medical College is sponsoring a Phase I trial to assess the safety of daratumumab—a CD38-directed monoclonal antibody—administered after TBI-based myeloablative conditioning and allogeneic HCT in children, adolescents, and young adults with high-risk T-cell ALL or T-cell lymphoma. The trial will evaluate three dose levels with expansion and correlate outcomes using pre- and post-HCT NGS-MRD, T-cell repertoire, and immune reconstitution studies in patients treated at multiple centers.