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RECRUITING
NCT04981119

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

Sponsor: A2 Biotherapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2021-10-29

Completion Date

2029-04

Last Updated

2026-02-13

Healthy Volunteers

No

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.

Locations (16)

Banner Health

Gilbert, Arizona, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

City of Hope

Duarte, California, United States

University of California San Diego

La Jolla, California, United States

Stanford University

Palo Alto, California, United States

UCLA Medical Center

Santa Monica, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital/Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

NYU Langone Medical Center

New York, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States