Study of Early Second Infusion of CD19 CAR-T Therapy Guided by ctDNA in Adults with Relapsed or Refractory Large B-Cell Lymphoma

What this Trial Is About

This trial investigates the safety and effectiveness of an early second infusion of CD19 CAR T-cell therapy in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. Researchers aim to find out if this early second infusion improves the complete remission rate at 3 months and long-term survival at 1 year, while also assessing side effects like cytokine release syndrome, neurotoxicity, and infections. The study is a single-arm, prospective trial enrolling 15 participants who have not responded to previous treatments. All participants undergo leukapheresis to collect T cells for manufacturing the CAR-T therapy. Before infusion, they receive chemotherapy with fludarabine and cyclophosphamide to prepare their body. They receive an initial CAR-T infusion at a dose of 2 million cells per kilogram, followed by a second infusion of the same dose if circulating tumor DNA ctDNA remains positive or imaging shows incomplete response within 60 days. The study includes ctDNA monitoring via liquid biopsy at multiple time points up to 12 months. Participants are closely monitored in the hospital for at least 14 days after each infusion to manage potential side effects. Follow-up visits include blood tests, ctDNA analysis, and PETCT scans at scheduled intervals for up to a year. Safety assessments continuously track adverse events such as cytokine release syndrome severity, neurological symptoms, and infections. The main outcome measured is the complete remission rate at 3 months, along with other survival outcomes and safety results.

Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma