Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
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
Conditions
Interventions
A2B694
Autologous logic-gated Tmod CAR T cells
A2B543
Autologous logic-gated Tmod CAR T cells
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