RecruitingPhase 2NCT07256210

Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation

Phase I/II Clinical Trial of mbIL21 ex Vivo-expanded Donor-derived NK-cell Infusions With Hematopoietic Stem Cell Transplantation for Disease Relapse Prophylaxis in Pediatric and Young Adult Patients With Chemorefractory or Minimal Residual Disease Positive Acute Leukemia


Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Enrollment

15 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This pilot clinical trial aims to evaluate the feasibility, adverse reactions and maximum tolerated dose of mbIL21 ex vivo-expanded donor-derived NK-cell infusions before and after haploidentical or matched-related hematopoietic stem cell transplantation in a cohort of pediatric and young adult patients with chemorefractory or minimal residual disease (MRD) positive acute leukemia.


Eligibility

Min Age: 1 MonthMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether infusions of natural killer (NK) cells donated by a matched donor can help prevent leukemia from coming back after a bone marrow transplant (stem cell transplant). NK cells are part of the immune system and can attack cancer cells. **You may be eligible if...** - You are between 0 and 25 years old (or your guardian consents if you are under 18) - You have been diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or certain other high-risk blood cancers - You have undergone or are planning a haploidentical stem cell transplant (from a half-matched donor) - Your disease meets specific criteria for high relapse risk **You may NOT be eligible if...** - You have active uncontrolled infection - Your organ function does not meet the required thresholds - Your cancer has relapsed after transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALDonor-derived Natural Killer Cell

These are total doses for two infusions. The first NK-cell infusion on day -12 comprises 2/3 of total NK-cell dose and the second NK-cell infusion approximately on day +5 consists of 1/3 of total NK-cell dose.


Locations(1)

Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology

Moscow, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07256210


Related Trials