RecruitingPhase 1Phase 2NCT06051695

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

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


Sponsor

A2 Biotherapeutics Inc.

Enrollment

474 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an advanced type of CAR T-cell therapy (a personalized immune treatment) for solid tumors that have a specific genetic feature — loss of a certain immune marker (HLA-A*02) — combined with expression of a protein called mesothelin. This therapy is designed to attack only cancer cells while sparing healthy tissue. **You may be eligible if...** - You were previously enrolled in the BASECAMP-1 screening study with confirmed tumor characteristics - You have advanced, unresectable, or metastatic colorectal, lung, pancreatic, ovarian, mesothelioma, or other solid tumors expressing mesothelin - You have already tried required prior therapies for your cancer type - You are in good overall health and have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have not completed the required pre-screening (BASECAMP-1) process - You have significant organ dysfunction - You have active autoimmune disease or are on immune-suppressing drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALA2B694

Autologous logic-gated Tmod CAR T cells

BIOLOGICALA2B543

Autologous logic-gated Tmod CAR T cells

DIAGNOSTIC_TESTxT 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

View Full Details on ClinicalTrials.gov

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NCT06051695


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