TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Recruiting · NCT07246304 · Interventional (participants receive a specific treatment) · Lead sponsor: TCRCure Biopharma Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
TC-D101 CAR-T
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- The Jinling Hospital - Nanjing, Jiangsu, China