An Observational Study Obtaining Solid Tumor Tissue and Collecting Blood Cells for CAR T-Cell Therapy Manufacturing

What this Trial Is About

Researchers are studying how often solid tumor cancers lose a protein called Human Leukocyte Antigen (HLA) by using next generation sequencing. The study focuses on participants with solid tumors who have a high risk of relapse and incurable disease. This observational study does not provide treatment but collects important information that may help in managing participants' disease and preparing for future therapy options. Participants will first be screened for their HLA type and tumor characteristics through next generation sequencing of archived tumor tissue. Those with specific tumor changes involving HLA loss will undergo a procedure called apheresis to collect their white blood cells, mainly T cells. These collected cells will be stored for potential use in manufacturing CAR T-cell therapy if their cancer relapses. The study includes screening, enrollment for apheresis, a safety follow-up a week later, and a two-year long-term follow-up. During the study, participants will provide tumor samples and blood for testing and cell collection. Researchers will monitor how many participants qualify for future CAR T-cell therapy studies and how often HLA loss occurs in tumors. They will also watch for any adverse events related to the apheresis procedure within seven days. Follow-up will continue for up to two years to observe participants' outcomes and safety.

Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing