TC-D101 CAR-T cells for DLL3-positive small cell lung cancer that has returned
Tests TC-D101 CAR-T cells in adults with DLL3-positive small cell lung cancer.
Plain-language title generated from the registry record
Registry title: TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with small cell lung cancer that has come back or stopped responding, and whose tumour tests positive for DLL3. It tests TC-D101 CAR-T cell therapy.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Small cell lung cancer that has relapsed or does not respond to treatment (r/r SCLC). Standard therapy has failed or cannot be used. At least one measurable tumour lesion (RECIST 1.1). Life expectancy of at least 3 months. ECOG performance status 0-1.
- Earlier treatment
- Standard therapy has failed or cannot be used. People who had prior cell or gene therapy cannot join.
- Biomarker or test result
- DLL3-positive, confirmed by immunohistochemistry.
Main reasons for not taking part
- Primary brain or spinal cord cancer, or uncontrolled spread to the brain or spinal cord
- Another cancer within the past 5 years (with a few exceptions)
- Active or past autoimmune disease
- Weakened immune system, including HIV positivity
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07246304, who can take part
Where in China
- The Jinling HospitalNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- TCRCure Biopharma Ltd.
- Trial code
- NCT07246304
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer
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.
Inclusion: 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: Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation; 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.