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New treatment option for Small Cell Lung Cancer ( SCLC )
Official title TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
ClinicalTrials.gov ID: NCT07246304
What this study is testing
What is TC-D101 CAR-T?
TC-D101 CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer ( sclc ).
Also referred to as Fludarabine, Cyclophosphamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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. 11\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.