using Natural killer cells in AML

Phase 1 clinical trial using ex vivo-expanded memory-like natural killer (NK) cells isolated from third-party donor after haploidentical transplantation in pediatric acute myeloid leukemia AML patients

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150730023417N3

Enrollment

Registered

2025-10-01

Start date

2025-09-16

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Acute myeloid leukemia (AML). Condition 2: 2)graft versus host disease (GVHD). Condition 3: Relapse in leukemia. Acute myeloblastic leukemia Graft-versus-host disease Acute myeloblastic leukemia, in relapse

Interventions

Intervention group: In the first phase of the study, based on the evaluation of the donor and recipient, a haploidentical donor will be selected, and hematopoietic stem cell transplantation will be pe

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Pediatric AML patients (under 18 years of age) Received HSC transplant from a haploidentical donor full consent of the patient's legal guardian

Exclusion criteria

Exclusion criteria: patents legal guardians refusal disapproval of the patient's physician based on their clinical symptoms at the time unfavorable reaction to the NK injection (applicable to the second or third injections)

Design outcomes

Primary

Measure	Time frame
Determining relapse in patients receiving ML NK cells is monitored at 100 days, 1 year, and 2 years post-treatment based on minimal residual disease (MRD). Timepoint: The effect of patients’ memory natural killer cells on relapse of myeloid leukemia will be evaluated at 100 days and one year after transplantation. Method of measurement: Post-transplant disease relapse (Minimal Residual Disease) will be assessed by flow cytometry on peripheral blood or bone marrow samples taken at day 100 and one year after transplantation.	—

Measure

Time frame

Determining relapse in patients receiving ML NK cells is monitored at 100 days, 1 year, and 2 years post-treatment based on minimal residual disease (MRD). Timepoint: The effect of patients’ memory natural killer cells on relapse of myeloid leukemia will be evaluated at 100 days and one year after transplantation. Method of measurement: Post-transplant disease relapse (Minimal Residual Disease) will be assessed by flow cytometry on peripheral blood or bone marrow samples taken at day 100 and one year after transplantation.

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Secondary

Measure	Time frame
The effect of infusion of third-party donor memory natural killer cells on the incidence and severity of acute or chronic graft-versus-host disease will be evaluated. Timepoint: The effect of infusion of third-party donor memory natural killer cells on the incidence and severity of graft-versus-host disease at day +100 and during a one-year follow-up period will be examined. Method of measurement: A questionnaire designed based on the graft-versus-host disease diagnostic criteria according to the National Institutes of Health protocol will be used.	—

Measure

Time frame

The effect of infusion of third-party donor memory natural killer cells on the incidence and severity of acute or chronic graft-versus-host disease will be evaluated. Timepoint: The effect of infusion of third-party donor memory natural killer cells on the incidence and severity of graft-versus-host disease at day +100 and during a one-year follow-up period will be examined. Method of measurement: A questionnaire designed based on the graft-versus-host disease diagnostic criteria according to the National Institutes of Health protocol will be used.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Ali Hamidieh

Tehran University of Medical Sciences

aahamidieh@tums.ac.ir00981593270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026