Phase 1 Trial of Bispecific CD19 and CD22 CAR T Cell Therapy for Adolescents and Adults with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

This research is focused on adolescents and adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL, including specific lymphoma types such as Mantle Cell Lymphoma and CNS lymphoma. The study aims to evaluate the safety and tolerability of a new treatment using chimeric antigen receptor T cells CAR T cells that target both CD19 and CD22 proteins. The goal is to find the maximum safe dose of these CD19x22 CAR T cells and to determine the recommended dose for further studies. Participants receive lymphodepleting chemotherapy followed by an infusion of the CD19x22 CAR T cells. The trial uses a standard 33 design to escalate doses starting at different levels across three cohorts non-CNS B-cell lymphoma, Mantle Cell Lymphoma, and CNS lymphoma. This is an open-label, single-group phase 1 study where all participants receive the investigational CAR T cell therapy. During the trial, participants undergo screening and evaluations including imaging and laboratory tests to confirm eligibility and disease status. Researchers will monitor safety and tolerability over 12 months after infusion and assess treatment response at 90 days and one year. Additional assessments include manufacturing feasibility and infusion safety. Participants are followed long term to evaluate survival, remission duration, and response rates, with regular clinical visits and monitoring throughout the study period.

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients