Actively Recruiting
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
Led by A2 Biotherapeutics Inc. · Updated on 2026-02-20
474
Participants Needed
12
Research Sites
269 weeks
Total Duration
On this page
Sponsors
A
A2 Biotherapeutics Inc.
Lead Sponsor
T
Tempus AI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in the BASECAMP-1 study with tissue showing loss of HLA-A*02 by next generation sequencing and with successful T cell collection and storage
- Histologically confirmed recurrent unresectable, locally advanced, or metastatic colorectal cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer, mesothelioma, or other solid tumors with mesothelin expression
- Measurable disease with lesions 1.0 cm or larger by CT scan
- Received prior required therapy for the appropriate solid tumor
- Adequate organ function as specified in the study protocol
- ECOG performance status of 0 to 1
- Life expectancy of at least 3 months
- Willing to comply with study assessments and long-term safety follow-up
You will not qualify if you...
- Disease suitable for local therapy or able to receive standard of care therapy that is curative rather than palliative
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Mesothelioma with pleural involvement extending into the peritoneum
- Cancer therapy within 3 weeks or 3 half-lives before infusion
- Radiotherapy within 28 days before infusion
- Significant cardiac disease such as unstable angina, arrhythmia, or myocardial infarction within the last 6 months
- New symptomatic pulmonary embolism or deep vein thrombosis within 3 months before enrollment unless adequately treated and stable
- History of interstitial lung disease requiring prolonged steroid or immune suppressive treatment within 1 year
- Requirement for supplemental home oxygen
- Pregnant or breastfeeding females of childbearing potential
- Male and female subjects of childbearing potential unwilling to use birth control from consent through 6 months post-infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Banner Health
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
UCLA Medical Center
Los Angeles, California, United States, 90404
Actively Recruiting
4
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
5
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33606
Actively Recruiting
7
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
9
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
10
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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