TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC

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.

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.