A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors

Exclusion criteria

• ✕. Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI.
• ✕. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, cardiac arrhythmia requiring antiarrhythmic or procedure, or other clinically significant cardiac disease within 12 months of enrollment
• ✕. Have a history of ASTCT Grade 4 CRS, Grade 3 or greater ICANS, or Grade 3 or greater IECHS. Participants with a history of lower grade CRS, ICANS, or IECHS may be eligible, pending review and approval by the Medical Monitor.
• ✕. History of stroke or transient ischemic attack (TIA) within 6 months of enrollment
• ✕. Systemic corticosteroid therapy \>10 mg of prednisone daily or equivalent within 7 days of enrollment.
• ✕. History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte.
• ✕. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.
• ✕. Concurrent receipt of another anti-cancer therapy. Have a history of acute mental status changes of unknown etiology within 6 months prior to enrollment, or any neurological or neurodegenerative disorder (e.g., Parkinson disease, Huntington disease, uncontrolled seizure disorder) that may increase the risk for or confound the assessment of neurotoxicity.