eligibility_summary
Adults ≥18 with SCLC or pulmonary LCNEC, relapsed/refractory after ≥1L or intolerant, ECOG 0–1, ≥1 measurable nonbrain lesion (RECIST 1.1), expected survival ≥12 weeks, adequate organ/bone marrow, contraception, consent. Exclude: allergy to SNC115/fludarabine/cyclophosphamide/tocilizumab, prior CAR-T/gene-modified or DLL3 therapy, uncontrolled effusions, untreated/symptomatic brain mets, significant thrombosis, autoimmune, cardiac, or infections.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SNC115 injection—an autologous anti‑DLL3 CAR‑T cell therapy (genetically engineered T cells expressing a chimeric antigen receptor to Delta‑like ligand 3). Mechanism: CAR engagement of DLL3 on tumor cells triggers T‑cell activation, cytokine release, and perforin/granzyme‑mediated cytotoxic killing, lymphodepleting chemotherapy (fludarabine/cyclophosphamide) is used pre‑infusion to promote CAR‑T expansion. Targets: DLL3, an aberrantly expressed ligand in the Notch pathway on small cell lung cancer and lung large cell neuroendocrine carcinoma cells, activates patient T cells to eliminate DLL3‑positive neuroendocrine tumor cells. Study focus: first‑in‑human dose escalation assessing safety and pharmacokinetics/cell kinetics.