TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small cell lung cancer(r/r SCLC) who have progressed after prior therapies. The primary objective i
| Condition(s) | Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small cell lung cancer(r/r SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC. |
| Who can participate | Inclusion Criteria: 1. Participants must voluntarily provide written informed consent. 2. Aged 18-75 years (inclusive). 3. Life expectancy ≥ 3 months. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. DLL3-positive r/r SCLC confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis. Exclusion Criteria: 1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV po |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | TCRCure Biopharma Ltd. |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2025-11-30 |
| NCT ID | NCT07246304 |
| Official listing | https://clinicaltrials.gov/study/NCT07246304 |