Evaluating Donor NK Cell Infusion with Low-Dose Interleukin-2 for Treating AML Relapse After Stem Cell Transplant

What this Trial Is About

Researchers are conducting an early clinical study to evaluate the safety, tolerability, and initial effects of donor natural killer NK cells combined with low-dose interleukin-2 for treating acute myeloid leukemia AML relapse after allogeneic hematopoietic stem cell transplantation allo-HSCT. This trial focuses on patients whose AML has returned following stem cell transplantation and aims to assess dose-related toxicities, adverse events, and disease response. Participants will receive injections of donor NK cells at escalating doses administered twice over two weeks, followed by daily low-dose interleukin-2 for 28 days. The NK cells used are non-genetically modified and derived from healthy donors. No preventive treatment for graft-versus-host disease will be given before or after the infusion. The study involves monitoring dose-limiting toxicities, adverse events, and pharmacokineticspharmacodynamics after treatment. During the study, participants will be closely monitored for safety and treatment response over one to three months. Assessments include measuring adverse events, complete remission rates, minimal residual disease status, and donor NK cell levels. Participants must provide informed consent and adhere to contraception requirements. The study is conducted at a single center and is sponsored by Peking University First Hospital, with a total study duration extending until mid-2027.

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.