A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors

Exclusion criteria

• ✕. Have had radiotherapy or another appropriate therapy for the brain or spinal metastases. The therapy must be completed at least 3 weeks prior to CLDN6 CAR-T administration,
• ✕. Have no neurological symptoms,
• ✕. Have stable brain or spinal disease on the computer tomography or magnetic resonance imaging scan within 3 weeks before CLDN6 CAR-T administration,
• ✕. Are not undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for the last 14 days prior to screening (≤10 mg prednisolone daily or equivalent),
• ✕. Do not require steroid therapy within 7 days before the first dose of CLDN6 CAR-T, and
• ✕. Do not have anticipated imminent fracture or cord compression due to spinal bone metastases.
• ✕. Ongoing or active infection requiring antibiotic/antiviral/antifungal therapy
• ✕. Concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV)