Phase I Study of Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 CAR T-Cell Therapy for Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and best dose of fludarabine and cyclophosphamide, with or without rituximab, before CD19 chimeric antigen receptor CAR T-cell therapy in adults with diffuse large B-cell lymphoma that has returned or not responded to previous treatment. This phase I trial assesses whether giving these chemotherapy drugs prior to CAR T-cell therapy can improve the treatment response by reducing normal T-cells and allowing the modified CAR T-cells to better target cancer cells. Participants receive one of six dosing regimens involving intravenous fludarabine and cyclophosphamide for several days before receiving CD19 CAR T cells by intravenous infusion on day 0. Some regimens include rituximab given intravenously on day -5. After the treatment, participants are followed closely with scheduled visits at 30, 60, and 90 days, then at 6 and 12 months, and annually for up to 15 years to monitor safety and treatment effects. During the study, participants undergo various assessments including safety monitoring for side effects and dose-limiting toxicities, measurements of treatment response such as overall and complete response rates, and evaluation of survival outcomes. The trial aims to successfully manufacture CAR T cells at a target dose and assess long-term safety and effectiveness. Participants health is regularly checked through laboratory tests and clinical evaluations throughout the study and follow-up periods.

Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma