NCT06682793

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

Study 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

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Interventions

A2B395BIOLOGICAL
Allogeneic logic-gated Tmod CAR T cells
xT CDx with HLA-LOH assayDIAGNOSTIC_TEST
An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device

Study Locations

FacilityCityStateCountry
Banner MD Anderson Cancer CenterGilbertArizonaUnited States
UCSD Moores Cancer CenterLa JollaCaliforniaUnited States
UCLA Medical CenterLos AngelesCaliforniaUnited States
Mayo ClinicJacksonvilleFloridaUnited States
Moffitt Cancer CenterTampaFloridaUnited States
Mayo ClinicRochesterMinnesotaUnited States
Washington UniversitySt LouisMissouriUnited States
NYU Langone HealthNew YorkNew YorkUnited States
The Ohio State UniversityColumbusOhioUnited States
Fred Hutch Cancer CenterSeattleWashingtonUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026