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.
• 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.