NCT06641648

A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined with Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Detailed description

This is a dose-escalation study of non-genetically modified natural killer cells derived from a healthy donor. The relapsed AML patients after allo-HSCT will receive donor NK cells injection s followed by low-dose interleukin-2. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.

Conditions

• Acute Myeloid Leukemia (AML)
• Acute Myeloid Leukemia (AML) Relapse
• NK Cell

Interventions

Type	Name	Description
DRUG	NK cell	Drug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China