A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (EVEREST-1)
Solid Tumor, Adult, Solid Tumor, Pancreatic Cancer
About this trial
This is an interventional treatment trial for Solid Tumor, Adult focused on measuring CAR T Cell, Solid Tumors, autologous, T cell, Carcinoembryonic Antigen, CEA, HLA-A2, Solid Tumors Expressing CEA, Pancreatic Cancer, PANC, CRC, Colorectal Cancer, NSCLC, Non-Small Cell Lung Cancer
Eligibility Criteria
Key Inclusion Criteria: Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02:01 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, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of >1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease). 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 Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion Radiotherapy within 28 days of A2B530 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. 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 A2B530
Sites / Locations
- City of HopeRecruiting
- UCLA Medical CenterRecruiting
- Mayo Clinic Jacksonville
- Moffitt Cancer CenterRecruiting
- Mayo Clinic RochesterRecruiting
- Washington UniversityRecruiting
- NYU Langone Medical CenterRecruiting
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
A2530
Patients receive Preconditioning Lymphodepletion (PCLD) Regimen followed by a single dose of A2B530 intravenously on day 0