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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
CD19-targeted chimeric antigen receptor T-cell therapy
Objective Response Rate (ORR)
Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review
Time frame: Up to 96 weeks
Complete Response Rate (CRR)
Proportion of subjects achieving complete response per 2014 Lugano classification by independent review
Time frame: Up to 96 weeks
Disease Control Rate (DCR)
Proportion of subjects with complete response, partial response, or stable disease
Time frame: Up to 96 weeks
Stable Disease Rate (SDR)
Proportion of subjects with stable disease per 2014 Lugano classification
Time frame: Up to 96 weeks
Duration of Response (DOR)
Time from first documentation of response (CR or PR) to disease progression or death from any cause
Time frame: Up to 96 weeks
Time to Response (TTR)
Time from TC011 infusion to first documented response (CR or PR)
Time frame: Up to 96 weeks
Progression-Free Survival (PFS)
Time from TC011 infusion to disease progression or death from any cause
Time frame: Up to 96 weeks
Overall Survival (OS)
Time from TC011 infusion to death from any cause
Time frame: Up to 96 weeks
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Incidence and severity of adverse events
Incidence, severity, and type of adverse events graded per CTCAE v5.0
Time frame: Up to 96 weeks