Umbilical Cord Blood NK Cell Therapy for High-Risk Pediatric Soft Tissue Sarcoma: Efficacy and Safety Study

Summary

This is a single-arm, open-label, non-blind, phase I/II clinical trial evaluating the safety and efficacy of umbilical cord blood natural killer (NK) cell in children with high-risk and relapsed/refractory soft tissue sarcoma (STS). Objective: Assess the safety and efficacy of NK cell in high-risk and relapsed/refractory STS patients. Observe the pharmacokinetics and pharmacodynamics of NK cells in these patients. Study Design: Single-arm, open-label, non-blind design. 40 patients with high-risk and relapsed/refractory STS will receive the NK cell combined with other treatment . The treatment regimen involves 8 doses of NK cells injected at specific time points over 3 months, followed by a 3-year follow-up period.

Timeline

Start

2024-11-01

Primary completion

2026-02-01

Completion

2028-02-01

Drugs

Indications