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RECRUITING
NCT06051695
PHASE1/PHASE2

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

Sponsor: A2 Biotherapeutics Inc.

View on ClinicalTrials.gov

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

Official title: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2024-04-03

Completion Date

2029-06

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

A2B694

Autologous logic-gated Tmod CAR T cells

BIOLOGICAL

A2B543

Autologous logic-gated Tmod CAR T cells

DIAGNOSTIC_TEST

xT CDx with HLA-LOH Assay

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

Locations (12)

Banner Health

Gilbert, Arizona, United States

UCSD Moores Cancer Center

La Jolla, California, United States

UCLA Medical Center

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Mayo Clinic

Jacksonville, Florida, 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

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States