Phase 12 Study of Target-Selected Allogeneic CAR-NK Cell Therapy for Adults With Relapsed or Refractory B2 Thymoma or Thymic Carcinoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of target-selected CAR-natural killer CAR-NK cell therapies in adults with relapsed or refractory B2 thymoma or thymic carcinoma. This Phase 12 study assigns participants to one of three groups based on tumor antigen expression CD30, CD5, or mesothelin to receive a matching CAR-NK treatment. The study explores a new approach using genetically modified immune cells to target these cancers. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three days before getting their assigned CAR-NK cell infusion on Day 0. In Phase 1, dose levels are gradually increased to find the maximum tolerated or recommended dose. Phase 2 expands enrollment to further assess safety and preliminary antitumor activity. A second CAR-NK infusion on Day 7 may be given if no severe side effects occur and product is available. During the study, participants undergo tumor antigen testing, blood and tumor sampling to monitor CAR-NK cell persistence, immune responses, and biomarkers. Safety is closely followed, especially for dose-limiting toxicities in the first 28 days after infusion. Long-term follow-up will monitor delayed side effects and survival. The full participation period includes screening, treatment, and extended observation as guided by gene therapy protocols.

Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma