Phase III Trial of Multi-Targeted 4SCAR-T Cell Therapy Against Neuroblastoma Using GD2, PSMA, and CD276 Antigens

What this Trial Is About

Researchers are evaluating a new 4SCAR-T cell therapy targeting three surface antigens GD2, PSMA, and CD276 in patients with relapsed or refractory neuroblastoma NB, a severe childhood tumor with poor survival despite current treatments. This study aims to assess the feasibility, safety, and effectiveness of this multi-targeted CAR-T cell approach. The research also seeks to understand how these modified T cells function and persist in patients over time. The investigational treatment involves gene-modified T cells designed to recognize and kill tumor cells expressing GD2, PSMA, and CD276. Each patients tumor will be tested to identify which antigens are highly expressed, allowing a personalized combination of two or three targets for the 4SCAR-T therapy. The CAR-T cells are infused intravenously at doses ranging from 1x106 to 1x107 cells per kilogram of body weight. This approach is intended to overcome the limited success of single-target CAR-T treatments in neuroblastoma. Participants will undergo evaluations to measure side effects, anti-tumor effects, CAR-T cell expansion, cytokine secretion, and survival over a period of up to three years. Tumor antigen expression is determined before treatment using immunohistochemistry or flow cytometry. Researchers will monitor patient health through physical exams, cardiac and liver function tests, blood counts, and oxygen levels. The study involves ongoing safety assessments and effectiveness monitoring to better understand treatment impact and patient outcomes.

4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma