Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma
brief summary
This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a). The primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.
detailed description
This is a multi-center, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of TC011, a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy, in adult patients with relapsed or refractory follicular lymphoma.
Eligible patients who meet all inclusion and exclusion criteria will undergo leukapheresis for the manufacture of TC011, followed by lymphodepleting chemotherapy and a single intravenous infusion of TC011. Patients will be followed according to the study schedule to assess efficacy and safety outcomes.
The primary efficacy endpoint is objective response rate assessed by independent review using standardized response criteria. Secondary endpoints include additional efficacy measures and safety evaluations. Exploratory assessments may include characterization of TC011-related cellular kinetics and biomarker analyses.
An independent Data Safety Monitoring Board will periodically review accumulated safety and efficacy data to ensure patient safety throughout the study.
official title
A Multi-center, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of TC011 in Patients With Relapsed or Refractory Follicular Lymphoma