TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TC-D101 CAR-T.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer
Overview
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.
Detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-D101 CAR-T cell therapy in patients with r/r SCLC. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-D101 CAR-T cell infusion, and (5) post-infusion follow-up.
Interventions
- Biological TC-D101 CAR-T
TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Primary outcome measures
- Safety of TC-D101 CAR-T cells [Time frame: Up to 24 months]
- Safety of TC-D101 CAR-T cells [Time frame: Up to 1 month]
Secondary outcome measures (1)
- Efficacy of TC-D101 CAR-T cells [Time frame: Up to 24 months]
Eligibility criteria
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.
11\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Jinling Hospital — Nanjing
Identifiers
NCT: NCT07246304 · D101-IIT-01