Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07256210
PHASE2

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

Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Month - 25 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-05-09

Completion Date

2027-10

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

BIOLOGICAL

Donor-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