Phase I Study of CD70-targeted CAR-T Therapy for Adults with Advanced or Metastatic CD70-positive Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new CAR-T cell therapy targeting CD70 in patients with advanced or metastatic solid tumors that express CD70. This phase I study aims to find the highest dose patients can safely receive and to recommend a dose for future studies. The trial focuses on patients who have not responded to or cannot tolerate standard treatments and have measurable tumors. The study has two groups receiving CD70-targeted CAR-T cells either by intravenous infusion or intraperitoneal injection. Each group includes three dose levels using a dose-escalation design called 33, with about nine patients planned for each group. Before receiving the CAR-T cells, patients are treated with Fludarabine and Cyclophosphamide. This is an open-label trial without randomization or masking. Participants will be closely monitored for adverse events and dose tolerance during the first 28 days after infusion. Researchers will also assess disease control, objective response rates, treatment duration, and pharmacodynamics over three months. Evaluations include imaging scans, blood tests, and clinical assessments. The total study duration includes safety monitoring, with ongoing follow-up to understand the therapys effects and safety profile.

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