TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC

NCT07246304 · tracked via the Priya Life Science China tracker

Sponsor

TCRCure Biopharma Ltd

Phase

Early Phase 1

Started

2026-06-10

Last updated

2026-10-26

Condition(s) studied

Small Cell Lung Cancer ( SCLC )CAR-T Cell Therapy

Investigational drug(s) / intervention(s)

TC-D101 CAR-T →

TC-D101 CAR-T: TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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 positivity. 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis B/C, syphilis). 8. Pregnant or breastfeeding women. 9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion. 11\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.

Primary outcome measure(s)

Safety of TC-D101 CAR-T cells — Up to 24 months
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Safety of TC-D101 CAR-T cells — Up to 1 month
Incidence of DLT

Trial sites (1)

Facility	City	Region	Status
The Jinling Hospital	Nanjing	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07246304 on ClinicalTrials.gov ↗ ← All trials in China