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Clinical Trials in the USA / NCT06051695
Recruiting Phase 1/2

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

NCT06051695 · tracked via the Priya Life Science USA tracker
Sponsor
A2 Biotherapeutics Inc.
Phase
Phase 1/2
Started
2024-04-03
Last updated
2026-06-12

Condition(s) studied

Solid Tumor, AdultColorectal CancerNSCLCNon Small Cell Lung CancerNSCLC, RecurrentNon-Small Cell Squamous Lung CancerPancreas CancerPancreatic NeoplasmColorectal AdenocarcinomaCRCColon CancerRectal CancerCancerOvarian CancerOvarian NeoplasmsMesotheliomaMesothelioma, MalignantOvary CancerLung CancerMESOM

Investigational drug(s) / intervention(s)

A2B694A2B543xT CDx with HLA-LOH Assay

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Key Inclusion Criteria: 1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy 2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT. 3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol 4. Has adequate organ function as described in the protocol 5. ECOG performance status of 0 to 1 6. Life expectancy of ≥3 months 7. Willing to comply with study schedule of assessments including long term safety follow up Key Exclusion Criteria: 1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative 2. Prior allogeneic stem cell transplant 3. Prior solid organ transplant 4. MESO with pleural involvement extending into the peritoneum 5. Cancer therapy within 3 weeks or 3 half lives of infusion 6. Radiotherapy within 28 days of infusion 7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months 8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated 9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year 10. Requires supplemental home oxygen 11. Females of childbearing potential who are pregnant or breastfeeding 12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Banner Health Gilbert Arizona Recruiting
UCSD Moores Cancer Center La Jolla California Recruiting
UCLA Medical Center Los Angeles California Recruiting
Stanford University Stanford California Recruiting
Mayo Clinic Jacksonville Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Washington University St Louis Missouri Recruiting
NYU Langone Medical Center New York New York Recruiting
The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06051695 on ClinicalTrials.gov ↗ ← All trials in the USA