Follicular Lymphoma (FL)
Conditions
Keywords
Follicular Lymphoma, CAR-T, CD19, Adoptive Cell Therapy, Immunotherapy
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.
Interventions
BIOLOGICALTC011 single-arm
CD19-targeted chimeric antigen receptor T-cell therapy
Sponsors
TICAROS Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to provide written informed consent. 2. Age ≥19 years at the time of screening. 3. Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification. 4. Relapsed or refractory disease after at least two prior systemic therapies including rituximab. 5. ECOG performance status ≤2. 6. Life expectancy ≥12 weeks. 7. At least one measurable lesion (long diameter ≥1.5 cm). 8. Adequate hepatic, renal, hematologic, pulmonary, and cardiac function. 9. Eligible for leukapheresis and successful manufacture of TC011. 10. Agreement to use effective contraception for at least 6 months after TC011 infusion.
Exclusion criteria
1. Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b. 2. Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities). 3. Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ. 4. Clinically significant cardiovascular disease within 6 months prior to screening. 5. Active central nervous system involvement by lymphoma. 6. Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply). 7. Active autoimmune or inflammatory neurologic disease. 8. Rapidly progressive disease requiring urgent therapy. 9. Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation. 10. Major surgery within 4 weeks prior to screening. 11. Use of investigational agents within 4 weeks prior to screening. 12. Known hypersensitivity to components of TC011. 13. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 96 weeks | Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | Up to 96 weeks | Proportion of subjects achieving complete response per 2014 Lugano classification by independent review |
| Disease Control Rate (DCR) | Up to 96 weeks | Proportion of subjects with complete response, partial response, or stable disease |
| Stable Disease Rate (SDR) | Up to 96 weeks | Proportion of subjects with stable disease per 2014 Lugano classification |
| Duration of Response (DOR) | Up to 96 weeks | Time from first documentation of response (CR or PR) to disease progression or death from any cause |
| Time to Response (TTR) | Up to 96 weeks | Time from TC011 infusion to first documented response (CR or PR) |
| Progression-Free Survival (PFS) | Up to 96 weeks | Time from TC011 infusion to disease progression or death from any cause |
| Overall Survival (OS) | Up to 96 weeks | Time from TC011 infusion to death from any cause |
| Incidence and severity of adverse events | Up to 96 weeks | Incidence, severity, and type of adverse events graded per CTCAE v5.0 |
Contacts
PRINCIPAL_INVESTIGATORWon Seok Kim, MD, PhD
Samsung Medical Center, Department of Hematology-Oncology
Outcome results
None listed