A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (EVEREST-2)
Solid Tumor, Adult, Colorectal Cancer, NSCLC
About this trial
This is an interventional treatment trial for Solid Tumor, Adult focused on measuring CAR T Cell, Solid Tumors, Autologous, T Cell, Mesothelin, MSLN, HLA-A2, Solid Tumors expressing MSLN, Pancreatic, Cell Therapy, Gene Therapy, blocker, Cancer, PANC, CRC, Colorectal Cancer, Lung Cancer, NSCLC, OVCA, MESOM, Ovarian Cancer, Mesothelioma
Eligibility Criteria
Inclusion Criteria: Key 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 A2B694 infusion Radiotherapy within 28 days of A2B694 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 of A2B694
Sites / Locations
- City of Hope
- UCSD Moores Cancer Center
- UCLA Medical Center
- Stanford University
- Moffitt Cancer Center
- Massachusetts General Hopsital/Dana Farber Cancer Center
- Mayo Clinic Rochester
- Washington University
- NYU Langone Medical Center
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
A2B694
Patients receive Preconditioning Lymphodepletion (PCLD) Regimen followed by a single dose of A2B694 intravenously on day 0