Phase 1 Open-Label Study of Anti-CD19 CAR-T Cell Therapy for Relapsed or Refractory Non-Hodgkin Lymphoma Including Burkitt and Marginal Zone Lymphomas

What this Trial Is About

Researchers are evaluating the safety and feasibility of infusing genetically modified autologous T cells that express a chimeric antigen receptor targeting the B cell surface antigen CD19. This open-label phase 1 study focuses on participants with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma NHL, including specific subtypes like Burkitt lymphoma, Marginal Zone Lymphoma, and Waldenstrm Macroglobulinemia. The trial aims to determine the safety profile and recommended dose for this CAR-T cell therapy. Participants undergo apheresis to collect their own lymphocytes, followed by manufacturing of the anti-CD19 CAR-T cells over approximately 13 to 14 days. During manufacturing, they receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Afterward, participants receive a single infusion of the CAR-T cells targeting CD19. The study includes dose escalation closed to enrollment and dose expansion cohorts based on lymphoma subtype, with follow-up planned for 12 months post-infusion and long-term monitoring up to 15 years. Throughout the study, participants are closely monitored for safety, including treatment-emergent adverse events and dose-limiting toxicities. Assessments include measuring response rates and survival outcomes. Follow-up visits occur during the first year post-infusion to track safety and efficacy, with survival status monitored over 15 years. This comprehensive evaluation aims to assess both the immediate and long-term effects of the CAR-T cell therapy in this patient group.

Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma