A2B395 CAR T-Cell Therapy for Colorectal Cancer
(DENALI-1 Trial)
Trial Summary
What is the purpose of this trial?
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
Research Team
John Welch, MD, PhD
Principal Investigator
A2 Biotherapeutics
Eligibility Criteria
This trial is for people with certain solid tumors (like colorectal, lung, breast, kidney cancers) that have a specific protein called EGFR and lack another marker known as HLA-A*02. Details on who can join are not fully provided but typically include meeting health standards and having the type of cancer being studied.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- A2B395
Find a Clinic Near You
Who Is Running the Clinical Trial?
A2 Biotherapeutics Inc.
Lead Sponsor