Actively Recruiting
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Led by TCRCure Biopharma Ltd. · Updated on 2025-11-24
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
TCRCure Biopharma Ltd.
Lead Sponsor
T
The Jinling Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily provide written informed consent.
- Age between 18 and 75 years inclusive.
- Life expectancy of 3 months or more.
- ECOG performance status of 0 or 1.
- Failed or unsuitable for standard therapy.
- At least one measurable lesion according to RECIST 1.1.
- DLL3-positive relapsed or refractory small cell lung cancer confirmed by immunohistochemistry.
- Adequate organ and bone marrow function.
- Participants of childbearing potential must use effective contraception.
- Adequate venous access for leukapheresis.
You will not qualify if you...
- Primary central nervous system malignancy or uncontrolled CNS metastases.
- Other malignancies within 5 years except treated non-melanoma skin cancer or carcinoma in situ.
- Active or history of autoimmune disease.
- Immunodeficiency including HIV positivity.
- Bleeding disorders.
- Clinically significant cardiovascular disease.
- Active infection including tuberculosis, hepatitis B/C, or syphilis.
- Pregnant or breastfeeding women.
- Clinically significant ascites.
- Uncontrolled pleural or pericardial effusion.
- Prior cell or gene therapy.
- Severe drug hypersensitivity history.
- Investigator-assessed unsuitability for trial participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Jinling Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
T
Tangfeng LV
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here