RecruitingNCT04981119

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

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


Sponsor

A2 Biotherapeutics Inc.

Enrollment

200 participants

Start Date

Oct 29, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This two-part study is first looking at whether certain solid tumors (colorectal, lung, pancreatic, and others) have a specific genetic change called HLA loss of heterozygosity (LOH) — where cancer cells hide from the immune system. In the second part, researchers will collect blood cells (via a process called apheresis) from eligible patients to manufacture CAR T-cell therapies that can specifically target those tumors. **You may be eligible if...** - You have been diagnosed with an advanced solid tumor (colorectal, lung, pancreatic, mesothelioma, or ovarian cancer) - In Part 2: Your tumor has a specific genetic pattern (HLA-A*02 heterozygous with HLA LOH confirmed by genetic testing) - Your cancer has spread or cannot be removed surgically - You are in good health overall (ECOG 0–1 for Part 2) **You may NOT be eligible if...** - You have had a bone marrow or solid organ transplant - You have had another cancer in the past 5 years (with some exceptions like early-stage skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04981119


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