RecruitingNot ApplicableNCT06848582

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

A Single-Arm, Non-Blind Clinical Study on the Efficacy and Safety of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-Risk, Recurrent/Refractory Soft Tissue Sarcoma

Sponsor

Sun Yat-sen University

Enrollment

40 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma (STS)

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.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether natural killer (NK) cells derived from umbilical cord blood — a type of immune cell therapy — are safe and effective for children with high-risk soft tissue sarcoma (a cancer of muscles, fat, or connective tissue) that has come back or spread. **You may be eligible if...** - You are 18 years old or younger - You have been diagnosed with high-risk soft tissue sarcoma - Your cancer has relapsed (come back), is refractory (not responding to treatment), or has spread to other parts of the body - Your general performance level is adequate (Karnofsky or Lansky score showing ability to carry out normal activities) - You or your parent/guardian can provide informed consent **You may NOT be eligible if...** - You have another serious active illness that would make this treatment unsafe - Your organ function (heart, liver, kidneys) is significantly impaired - You have had a stem cell transplant recently and have not recovered Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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