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ACTIVE NOT RECRUITING
NCT05736731
PHASE1/PHASE2

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

Sponsor: A2 Biotherapeutics Inc.

View on ClinicalTrials.gov

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

Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-04-28

Completion Date

2026-12

Last Updated

2025-04-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

A2B530

Autologous logic-gated Tmod CAR T-cells

DIAGNOSTIC_TEST

xT-Onco with HLA-LOH Assay

An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device

Locations (8)

Banner Health

Gilbert, Arizona, United States

University of California San Diego

La Jolla, California, United States

UCLA Medical Center

Los Angeles, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

NYU Langone Medical Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States