NCT07246304RecruitingEarly phase 1
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 10 Jun 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- TCRCure Biopharma Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07246304
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 24
- From 10 Jun 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Jinling Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.