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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
Trial Status: active
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 Criteria
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 Key
Exclusion Criteria
Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
Prior allogeneic stem cell transplant
Prior solid organ transplant
MESO with pleural involvement extending into the peritoneum
Cancer therapy within 3 weeks or 3 half lives of infusion
Radiotherapy within 28 days 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
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
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06051695.
