Phase II Study of Relmacabtagene Autoleucel and Sintilimab for Treating Relapsed or Refractory B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the combination of Relmacabtagene Autoleucel and Sintilimab to treat adults with relapsed or refractory B-cell lymphoma, including types such as diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. This phase II clinical trial aims to assess the treatments safety and effectiveness, focusing on the complete response rate three months after treatment. The study is sponsored by Sun Yat-sen University and involves participants aged 18 to 70 years with confirmed CD19-positive lymphoma. Participants will first undergo lymphodepletion therapy using intravenous fludarabine and cyclophosphamide over three days to prepare the body for the cellular therapy. Relmacabtagene Autoleucel, an investigational cell therapy, will then be infused intravenously between two and seven days after lymphodepletion. Starting 28 days after this infusion, patients will receive intravenous Sintilimab every three weeks for up to one year or until disease progression or intolerable side effects occur. During the study, participants will be closely monitored through various assessments, including evaluation of response to treatment at three months and ongoing follow-up for up to two years to track disease-free survival, progression-free survival, overall survival, and any adverse events. Researchers will also measure the objective response rate up to one year after infusion. Safety and tolerability will be assessed throughout the trial. Participants can expect regular visits and evaluations to closely observe their condition and treatment effects.

Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma