NCT05333705

Donor Immune Cell Therapy for Acute Myeloid Leukemia

Trial of Donor Immune Cell Therapy for Acute Myeloid Leukemia.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to introduce a new technology of donor NK cell infusion. NK cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors. In this study, NK cells will be separated from donated peripheral blood or umbilical cord blood. Eligible NK cells will be infused to patients with Acute myeloid leukemia (AML). This new therapy will probably induce their sustained remission and reduce recurrences.

Detailed description

Primary end point: To determine the rate of overall survival at 2 years of Interventional cohort Secondary end point: To determine the cumulative incidence of relapse at 2 years. To determine the rate of disease-free survival at 2 years. Describe the safety and toxicity of donor NK cell infusion. Study Design: This study is a phase I clinical trial. 15 eligible AML patients will be enrolled sequentially to receive detached NK cells product during induction or consolidation therapy. Refractory or relapsed patients and patients who achieved complete remission (CR) after induction therapy are included. They will receive anthracycline-based chemotherapy according to NCCN guidelines. At the same time, Cultured NK cells will be infused into patients after chemotherapy. Anti-allergic therapy and prophylaxis of graft versus host disease (GVHD) will be given before infusion. Treatment effect will be measured and adverse effect will be treated and documented after intervention.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	infusion of natural killer cells	Umbilical cord blood or donated peripheral blood of healthy donors were collected and NK cells were sorted and cultured. NK cell production will be infused after chemotherapy

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-07-01
• Completion: 2024-09-01
• First posted: 2022-04-19
• Last updated: 2022-04-19

Locations

1 site across 1 country: China