Phase 1 Study of CD70-targeted CAR-T Cell Therapy for Advanced or Metastatic CD70-positive Solid Tumors Evaluating Safety, Dosage, and Effectiveness with Intravenous and Intraperitoneal Administration

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD70-targeted CAR-T cells in treating patients with CD70-positive advanced or metastatic solid tumors. This phase 1, single-center study involves two groups based on the delivery method intravenous infusion and intraperitoneal injection. The study aims to find the recommended doses and infusion patterns for these treatments using a dose-escalation design. Each group undergoes two phases a dose discovery phase with four dose levels using a 33 design to recruit about 12 subjects, followed by a dose expansion phase where one or two dose levels are further tested for safety and efficacy with about 6 subjects per dose group. Before CAR-T cell infusion, patients receive lymphodepletion with fludarabine and cyclophosphamide. The doses range from 1 to 10 million cells per kilogram. During the study, participants will be closely monitored for side effects and treatment responses. Researchers will measure adverse events within 28 days and determine the maximum tolerated dose. Effectiveness outcomes include disease control rate, objective response rate, duration of response, progression-free survival, and overall survival over periods up to two years. The study also evaluates the behavior of CAR-T cells in the body over three months. Participants organ functions, quality of life, and safety will be regularly assessed throughout the trial.

A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors