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

Recruiting now · Early Phase 1

Conditions studied: Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy

In brief

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.

Key facts

Study ID

NCT07246304

Run by

TCRCure Biopharma Ltd.

People needed

24

Starts

2025-11-30

Expected to finish

2028-11-30

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must voluntarily provide written informed consent.
• Aged 18-75 years (inclusive).
• Life expectancy ≥ 3 months.
• ECOG performance status 0-1.
• Failed or unsuitable for standard therapy.
• At least one measurable lesion per RECIST 1.1.
• DLL3-positive r/r SCLC confirmed by immunohistochemistry.
• Adequate organ and bone marrow function.
• Effective contraception required for participants of childbearing potential.
• Adequate venous access for leukapheresis.

You may not qualify if…

• Primary CNS malignancy or uncontrolled CNS metastases.
• Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
• Active autoimmune disease or history of autoimmune disease.
• Immunodeficiency, including HIV positivity.
• Bleeding disorders (inherited or acquired).
• Clinically significant cardiovascular disease.
• Active infection (including tuberculosis, hepatitis B/C, syphilis).
• Pregnant or breastfeeding women.
• Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.
• Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.

Where it is running

• The Jinling Hospital — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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