Actively Recruiting
Phase III Study of DJI136, a DLL3-Targeted CAR-T Therapy, for Adults with Extensive-Stage Small Cell Lung Cancer
Led by Novartis Pharmaceuticals · Updated on 2026-06-23
80
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating DJI136, a DLL3-targeted CAR-T therapy, in adults with extensive-stage small cell lung cancer ES-SCLC who have experienced disease progression after chemotherapy. This Phase III, open-label, multi-center study aims to find the recommended dose and assess safety, tolerability, and early signs of effectiveness. The trial includes patients who meet specific medical criteria and have measurable tumors. The study begins with a Phase I dose escalation where patients receive DJI136 through intravenous infusion. This phase includes two parts Part A for patients with ES-SCLC after progression on one or more chemotherapy regimens, and an optional exploratory component. Phase II may follow with two groups, including one receiving the recommended dose from Phase I. Another exploratory group is optional. Participants will undergo assessments including tumor response evaluations, monitoring for side effects and serious adverse events, and blood tests to measure drug levels up to about two years. Safety and dose-limiting toxicities will be closely observed early on. Follow-up visits will check overall response rates and disease control. The study duration spans from initial treatment through long-term evaluation of outcomes and safety.
CONDITIONS
Brief Title
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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