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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.
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
Conditions
Interventions
A2B395
Allogeneic logic-gated Tmod CAR T cells
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