An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing
A2 Biotherapeutics Inc.
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.
Description
Background: Human Leukocyte Antigen (HLA) is a protein on the outside of cells that allows the immune system to recognize it's own cells as normal and leave them alone or respond if infected with a virus or bacteria, or a tumor cell. HLA might not be expressed normally on cancer cells. This may be why cancer can grow undetected by the immune system and is referred to as a tumor escape mechanism. Tumor escape can occur for many reasons, but one reason is Loss of Heterozygosity (LOH). LOH is the loss of one of the genes that encodes HLA protein. A2 Biotherapeutics, Inc. (A2 Bio) is developing t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 (CI…
Interventions
- OtherApheresis
Apheresis procedure performed for collection of PBMCs.
- Diagnostic TestNext Generation Sequencing (NGS)
NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
- Diagnostic TestLong Range NGS HLA typing
Long range NGS on whole blood to determine germline HLA type.
Locations (16)
- Banner HealthGilbert, Arizona
- Mayo Clinic HospitalPhoenix, Arizona
- City of HopeDuarte, California
- University of California San DiegoLa Jolla, California
- Stanford UniversityPalo Alto, California
- UCLA Medical CenterSanta Monica, California