A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer

Exclusion Criteria

• •Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to screening, unless treated with curative intent
• •Current treatment with systemic corticosteroids (defined as a dose greater than the equivalent of prednisone 10 mg/day)
• •Active autoimmune disease (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease or multiple sclerosis) or a history of severe autoimmune disease requiring prolonged immunosuppressive therapy (any immunosuppressive therapy within 6 weeks prior to screening visit)
• •Current human immunodeficiency virus (HIV), hepatitis C virus, hepatitis B virus infections; Patients who are hepatitis B core antigen positive, hepatitis B surface antigen negative, should have a quantitative viral load measured; If viral load is undetectable, the patient will not be excluded if hey are able to be treated with anti-viral medication for at least 7 days prior to lymphodepletion until at least 6 months after infusion with viral load and ALT monitoring
• •Active or uncontrolled medical or psychological condition that would preclude participation
• •History of seizure disorder
• •Prior allogeneic stem cell transplant
• •Central nervous system malignancy
• •History of severe infusion reaction to monoclonal antibodies or biological therapies, or to study product excipients that would preclude the patient safely receiving CART-PSMA-TGFβRDN cells
• •History of being previously treated with a J591 antibody-based therapy
• •Ferritin levels ≥ 4x the upper limit of normal prior to apheresis or prior to the start of lymphodepleting chemotherapy
• •Active or recent (within the past 6 months prior to apheresis or lymphodepletion) cardiovascular disease, defined as (1) New York Heart Association Class III or IV heart failure, (2) unstable angina, (3) a history of recent (within 6 months) myocardial infarction or sustained (\> 30 second) ventricular tachyarrhythmias, or (4) cerebrovascular accident
• •Any active infection currently being treated or any infection within the last 6 weeks that required 7 days or more of IV antibiotics or any active infection within the last 4 weeks that requires use of oral antibiotics. Patients may be eligible once these timeframes elapse and with evidence that the infection has completely resolved
• •Have inadequate venous access for or contraindications for the apheresis procedure
• •Must agree not to participate in a conception process or must agree to a highly effective method of contraception