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.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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).

Eligibility criteria

Qualifiers

Age ≥ 18 years old,;

Expected survival period ≥ 3 months;

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;

Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;

Disqualifiers

Central nervous system involved;

Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.

History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;

Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;

Trial design

Treatments tested in this trial

  • NK cell

Treatment groups

12 Participants
are divided into 1 treatment group