Actively Recruiting
Phase III Study of IM19 CAR-T Cell Therapy for Adults with Relapsed or Refractory CD19-Positive Non-Hodgkins Lymphoma
Led by Beijing Immunochina Medical Science & Technology Co., Ltd. · Updated on 2020-12-08
52
Participants Needed
1
Research Sites
678 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of IM19 CAR-T cell therapy in adults with relapsed or refractory CD19-positive non-Hodgkins lymphoma. This phase III study includes a phase I single-center portion focusing on safety and a phase II multi-center portion assessing treatment efficacy for this aggressive lymphoma type. Participants receive IM19 CAR-T cells administered at two different dose levels. Before the cell infusion, all patients undergo treatment with fludarabine and cyclophosphamide for three days to prepare the body. The study is designed to monitor responses and safety throughout treatment. During the trial, researchers will assess the objective response rate at 90 days as the primary outcome. Participants will be monitored for safety and treatment effects, with evaluations based on established lymphoma response criteria. The study aims to enroll adults aged 18 and older and includes informed consent and follow-up measures to track progress and side effects.
CONDITIONS
Brief Title
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
Research Team
F
Fei Wu, MD
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