Clinical Trial

A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression

Study acronym: EVEREST-1

Active, Not Recruiting Phase 1/2

Summary

The goal of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the maximum or recommended dose of A2B530 that is safe for patients * Phase 2: Does the recommended dose of A2B530 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 and Apheresis in BASECAMP-1 (NCT04981119) * Preconditioning Lymphodepletion (PCLD) Regimen * A2B530 Tmod CAR T cells at the assigned dose

Protocol Amendment History 20 amendments

This ClinicalTrials.gov record has been amended 20 times since 2023-02-10; most recent amendment 2025-04-23.

Status change: Recruiting → Active, Not Recruiting 2025-04-23

Status change: Not Yet Recruiting → Recruiting 2023-04-24

Trial Details

NCT Number	NCT05736731
Lead Sponsor	A2 Biotherapeutics Inc. Collaborators: Tempus AI
Conditions	Solid Tumor, Adult, Solid Tumor, Pancreatic Cancer, Pancreatic Neoplasms, Pancreas Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Recurrent, Non-Small Cell Squamous Lung Cancer +8 more
Enrollment	160 participants
Start Date	2023-04-28
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-25