Exploring TC-D101 CAR-T Cell Therapy for Adults With DLL3-Positive Relapsed or Refractory Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive relapsed or refractory primary small cell lung cancer SCLC who have progressed after previous treatments. This early phase 1, single-arm, open-label trial aims primarily to find the maximum tolerated dose of TC-D101 and secondarily to assess its preliminary clinical effects in SCLC. The study involves five stages screening patients, collecting peripheral blood mononuclear cells PBMCs, administering lymphodepletion chemotherapy with fludarabine and cyclophosphamide, infusing a single dose of TC-D101 CAR-T cells, and conducting follow-up after infusion. Participants receive TC-D101 CAR-T cells following the lymphodepletion chemotherapy to evaluate their response and safety. Participants will be monitored for safety up to 24 months, with a focused safety assessment within the first month after infusion. Researchers will also observe the treatments efficacy during the 24 months follow-up. Evaluations include physical exams, laboratory tests, imaging, and other assessments to track health status, treatment effects, and adverse events throughout the study period.

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