Tests mesothelin-targeting CAR T cells in adults with solid tumors
Tests modified immune cells in adults with mesothelin-positive solid tumors that have lost HLA-A*02.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Columbus, Gilbert, Jacksonville, La Jolla, Los Angeles, Nashville, New York, Rochester, Seattle, St Louis, Stanford, and Tampa, United StatesSee the 12 sites
- Phase
- Phase 1/2
Where in United States
- The Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
- Banner HealthGilbert, United StatesTaking people
- Mayo ClinicJacksonville, United StatesTaking people
- UCSD Moores Cancer CenterLa Jolla, United StatesTaking people
- UCLA Medical CenterLos Angeles, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- NYU Langone Medical CenterNew York, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Washington UniversitySt Louis, United StatesTaking people
- Stanford UniversityStanford, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- A2 Biotherapeutics Inc.
- Trial code
- NCT06051695
- Record updated
- 12 June 2026
- Original description
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.Read full original descriptionShow less
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
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
Inclusion: 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; 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; Received previous required therapy for the appropriate solid tumor disease as described in the protocol; Has adequate organ function as described in the protocol; ECOG performance status of 0 to 1; Life expectancy of ≥3 months; Willing to comply with study schedule of assessments including long term safety follow up.
Exclusion: Prior allogeneic stem cell transplant; Prior solid organ transplant; Radiotherapy within 28 days of infusion; 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; Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative; Cancer therapy within 3 weeks or 3 half lives of infusion; Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months; 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; MESO with pleural involvement extending into the peritoneum; Requires supplemental home oxygen; Females of childbearing potential who are pregnant or breastfeeding; 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.