Phase 1 Study of CD70-Targeted CAR-T Cell Therapy for Advanced CD70-Positive Solid Tumors Using Intravenous, Intrapleural, or Intraperitoneal Infusion

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of a new type of treatment called CD70-targeted CAR-T cell therapy in adults with advanced solid tumors that express the CD70 protein. This open-label, phase 1 study aims to determine how the treatment behaves in the body, the best dose, and infusion schedule for patients with advanced cancers such as renal cell carcinoma, lung cancer, anaplastic thyroid carcinomas, ovarian cancer, cervical cancer, and thymic carcinoma. Participants will be assigned to one of three groups based on how the CAR-T cells are infused intravenously, into the pleural space, or into the peritoneal cavity. The study has two parts within each group a dose-escalation phase where increasing doses are tested in small groups, and a dose-expansion phase where more patients receive the selected dose to better assess safety and early signs of effectiveness. Before receiving CAR-T cell infusions, patients undergo conditioning therapy with Fludarabine and Cyclophosphamide. During the study, participants will be closely monitored for safety and side effects for at least one month after infusion. Researchers will also assess disease control at one and three months, study how the CAR-T cells move and persist in the body, and observe inflammatory responses following treatment. Participants will have regular assessments, including clinical exams and laboratory tests, to evaluate treatment effects and safety throughout the study duration.

CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors