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
Study ID
NCT07256210
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Donor-derived Natural Killer Cell — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Dec 1, 2025
Start date
May 9, 2025
Status verified
Jan 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Biological: Donor-derived Natural Killer Cell Infusions

Primary Outcome Measure

Proportion of patients who received the planned dose of NK cells without adverse reactions grade ≥3 according to CTCAE v5.0 [ Time Frame: 180 days from the last administration of donor NK cells ]

Central Contacts

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