Study of Gene Therapy Using Anti-CD70 CAR-Modified Blood Cells for Adults with Unresectable CD70-Expressing Cancers

What this Trial Is About

Researchers are studying a new gene therapy for adults aged 18 to 72 with unresectable cancers that express CD70, such as renal cell carcinoma, pancreatic cancer, breast cancer, melanoma, and ovarian cancer. This phase III study aims to evaluate the safety and effectiveness of modifying a persons white blood cells with an anti-CD70 chimeric antigen receptor CAR to target and shrink tumors. The therapy involves gene transfer using a virus to change the patients peripheral blood lymphocytes. Participants undergo screening including medical history, physical exams, scans, and blood tests. Eligible patients have their blood cells collected through leukapheresis, which separates white blood cells for modification. After a preparative chemotherapy regimen with cyclophosphamide and fludarabine, the modified cells are infused intravenously, followed by high-dose aldesleukin. The treatment involves hospitalization for recovery and an extended antibiotic course for six months. Leukapheresis may be repeated during the study. Participants will visit the clinic regularly for up to two years, starting every one to three months in the first year and later every six months or as advised by their physician. Each visit includes lab tests, imaging, and physical exams to monitor tumor size, treatment effects, and safety. The main outcomes measured are treatment-related side effects and tumor response at multiple time points after cell infusion. The study is conducted by the National Cancer Institute and follows patients until 2030.

Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers