RecruitingPhase 1Phase 2NCT06682793

A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression


Sponsor

A2 Biotherapeutics Inc.

Enrollment

240 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of CAR-T therapy called A2B395 — an "off-the-shelf" (donor-derived) engineered immune cell treatment — that is designed to target solid tumors expressing a protein called EGFR, specifically in patients whose cancer cells have lost a specific immune marker (HLA-A*02). **You may be eligible if...** - You have confirmed advanced, unresectable colorectal, lung, head/neck, breast (triple-negative), kidney, or other solid tumor cancer - Your tumor expresses EGFR and has lost HLA-A*02 (confirmed by genetic testing) - You have received required prior therapies and your cancer has progressed - You are in good physical condition (ECOG 0–1) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have active autoimmune disease or brain metastases requiring treatment - You have had a prior allogeneic stem cell transplant or organ transplant - Your organs are not functioning well enough to tolerate CAR-T therapy 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

BIOLOGICALA2B395

Allogeneic logic-gated Tmod CAR T cells

DIAGNOSTIC_TESTxT CDx with HLA-LOH assay

An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device


Locations(10)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

UCSD Moores Cancer Center

La Jolla, California, United States

UCLA Medical Center

Los Angeles, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Fred Hutch Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06682793


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