Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
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…
Conditions studied
Solid Tumor, Adult, Colorectal Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, CRC, NSCLC, Pancreas Cancer, Mesothelioma, Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Mesothelioma, Malignant, Mesothelioma; Lung, Cancer, Triple Negative Breast Cancer (TNBC), Renal Cell Carcinoma (Kidney Cancer), Head and Neck Squamous Cell Carcinoma HNSCC
About this study
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.
Interventions
- Other: Apheresis — Apheresis procedure performed for collection of PBMCs.
- Diagnostic Test: Next Generation Sequencing (NGS) — NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
- Diagnostic Test: Long Range NGS HLA typing — Long range NGS on whole blood to determine germline HLA type.
Primary outcomes
- Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis (up to 2 years)
- Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing (Screening)
Eligibility information
Study locations
- Banner Health, Gilbert, Arizona 85234 United States
- Mayo Clinic Hospital, Phoenix, Arizona 85054 United States
- City of Hope, Duarte, California 90101 United States
- University of California San Diego, La Jolla, California 92093 United States
- Stanford University, Palo Alto, California 94304 United States
- UCLA Medical Center, Santa Monica, California 90404 United States
- Mayo Clinic Jacksonville, Jacksonville, Florida 32224 United States
- Moffitt Cancer Center, Tampa, Florida 33136 United States
- Massachusetts General Hospital/Dana Farber Cancer Institute, Boston, Massachusetts 02114 United States
- Mayo Clinic Rochester, Rochester, Minnesota 55905 United States
Showing 10 of 16 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.