Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
This study examines how often solid tumors lose a key immune protein called HLA, which could affect cancer treatment. Participants will have their tumor tested using advanced genetic sequencing and will donate their own T cells (immune cells) that can be collected and stored for potential future CAR T-cell therapy treatment.
Key Objective: This trial aims to gather important information about HLA loss in solid tumors to help develop more effective personalized CAR T-cell treatments.
Who to Consider: Adults with solid tumors who are interested in contributing to research that could advance CAR T-cell therapy options and are willing to undergo genetic testing and cell collection procedures should consider enrolling.
Trial Parameters
Brief Summary
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Eligibility Criteria
Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria 1\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years. Part 1: Key Exclusion Criteria 1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer. 2. Prior allogeneic stem cell transplant. 3. Prior solid organ transplant. Part 2 : Key Inclusion Criteria 1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in t