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RECRUITING
NCT06682793
PHASE1/PHASE2

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

Sponsor: A2 Biotherapeutics Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-05-22

Completion Date

2030-03-31

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

A2B395

Allogeneic logic-gated Tmod CAR T cells

DIAGNOSTIC_TEST

xT 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