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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Drug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.
Peking University First Hospital
Beijing, Beijing Municipality, China
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs)
Time frame: 1 month
Treatment-related adverse events
Treatment-related adverse events
Time frame: 1 month
Complete response (CR)
Complete response (CR)
Time frame: 3 months
Proportion of subjects with minimal-residual disease (MRD) negative response
Time frame: 3 months
Peak levels of donor NK cells (maximum concentration or Cmax)
Time frame: 3 months
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