TC-D101 CAR-T therapy for DLL3-positive small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, open-label, early phase 1 dose-escalation trial gives a single infusion of TC-D101 CAR-T cells to adults with DLL3-positive relapsed or refractory SCLC to determine safety and the maximum tolerated dose. The protocol includes screening, leukapheresis to collect peripheral blood mononuclear cells, lymphodepletion chemotherapy, TC-D101 infusion, and scheduled post-infusion follow-up. Investigators will monitor CAR-T cell expansion and persistence, record adverse events, and measure tumor response by RECIST 1.1. Secondary goals include preliminary signs of clinical activity and durability of any responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Jinling Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Tangfeng LV
• Email: njzyjg80863256@163.com
• Phone: +862580863234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.