Clinical Trial

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

Study acronym: DENALI-1
Recruiting Phase 1/2
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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
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-11-07; most recent amendment 2025-09-03.
Status change: Not Yet Recruiting → Recruiting 2025-03-28
Trial Details
NCT Number NCT06682793
Lead Sponsor A2 Biotherapeutics Inc.
Conditions Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer), Cancer, Colon Cancer, Rectal Cancer, Lung Cancer +9 more
Enrollment 240 participants
Start Date 2025-05-22
Primary Completion 2029-03-31 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-09