Clinical Trial

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Study acronym: EVEREST-2
Recruiting Phase 1/2
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Summary
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill 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 and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen Tmod CAR T cells at the assigned dose
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2023-09-21; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2024-01-31
Trial Details
NCT Number NCT06051695
Lead Sponsor A2 Biotherapeutics Inc.
Collaborators: Tempus AI
Conditions Solid Tumor, Adult, Colorectal Cancer, NSCLC, Non Small Cell Lung Cancer, NSCLC, Recurrent, Non-Small Cell Squamous Lung Cancer, Pancreas Cancer, Pancreatic Neoplasm +12 more
Enrollment 474 participants
Start Date 2024-04-03
Primary Completion 2028-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-12