Acute Myeloid LeukemiaPhase 2NCT07256210
Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Donor-derived Natural Killer Cell in people with Acute Myeloid Leukemia and Acute Lymphoblastic T-cell Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 25 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic T-cell Leukemia, Mixed Phenotype Acute Leukemia
- What is being tested?
- Donor-derived Natural Killer Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 9 May 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient (age from 14 to 25 years) and/or patient's legal representative (age from 0 to 18 years) should provide written informed consent.
- Patients with one of the following disease:
- Acute myeloid leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,01% of bone marrow nucleated cells by flow cytometry);
- Acute T-lymphoblastic leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,1% of bone marrow nucleated cells by flow cytometry);
- Acute mixed phenotype leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,01% of bone marrow nucleated cells by flow cytometry).
- Patient is indicated to receive allo-HSCT according to actual clinical practice.
Show all 14Show fewer
- Haploidentical or matched related donor was chosen and is available for allo-HSCT (and NK-cell therapy).
- Patient's clinical status: Lansky/Karnowski index ≥50%.
- Kidney function: clearance of endogenous creatinine or glomerular filtration rate according to Schwarz equation ≥50 ml/min/1,73 m2.
- Liver function: total bilirubin ≤3 ULN except for Gilbert's disease, ALT/AST ≤3 ULN.
- Heart function: left ventricular ejection fraction ≥40%.
- Lung function: lung capacity ≥50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry ≥92% (without supplemental oxygen).
- Life expectancy ≥8 weeks.
- Patients who agree to long-term follow up for up to 2 years.
Who cannot join
- Inability to provide or withdrawal of written informed consent.
- Cellular therapy including allo-HSCT within prior 4 months period, absence of active signs of GVHD, sinusoidal obstruction syndrome, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome.
- Active hepatitis B, C or HIV infection.
- Pregnant or lactating women.
- Uncontrolled infection; principal investigator is the final arbiter of this criterion.
- Clinical signs of grade ≥3 CNS disorders (seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, organic brain syndrome, psychosis, coordination or movement disorder).
- Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Moscow, 117997
Michael Maschan, Profess, +7(495)287-6570, mmaschan@yandex.ru
About this study
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
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.
Read the detailed description
Rationale. In the context of treating children and young adults with high-risk or chemorefractory acute leukemia allogeneic hematopoietic stem cell transplantation (allo-HSCT) plays a crucial role. It is well known, that residual tumor cell volume at the time of allo-HSCT has a significant impact on its outcomes. The antileukemic effect of allo-HSCT in some hematologic malignancies is predominantly mediated by graft-versus-leukemia effect, which is an immune-mediated reaction of engrafted donor hematopoiesis against the recipient's tumor cells. The graft-versus-leukemia effect is generally ascribed to NK-cells conserved within the graft or arising from it early after transplantation.
Primary objective: to evaluate feasibility, safety and to identify the maximum tolerated dose (MTD) of mbIL21 ex vivo-expanded donor-derived NK-cell cells to be infused to children and young adults aged 1 to 25 years with chemorefractory or pre-transplant MRD-positive acute leukemia undergoing allo-HSCT.
Secondary objectives:
- To assess the short-term disease response to NK cell infusions as an adjunct to allo-HSCT.
- To assess the impact of NK cell infusions on reconstitution of main lymphocyte subpopulations in allo-HSCT recipients.
- To assess the impact of NK cell infusions on main allo-HSCT outcomes. Outline. This is a phase I, 3+3 dose-escalation study of NK-cells followed by a phase II study. Conditioning regimen will be split into two parts. Two donor NK-cell infusions will be carried out: after the first part of conditioning and early after transplant.
FIRST PART OF CONDITIONING: Patients receive fludarabine 40 mg/m2/day IV over 1 hour on days -14 and -13, thiotepa 10 mg/kg/course IV over 1 hour on days -14 and -13 and cyclophosphamide 500 mg/m2 IV over 1 hour on day -14.
SECOND PART OF CONDITIONING: Patients receive fludarabine 40 mg/m2/day IV over 1 hour on days -4 and -3, treosulfan 42 g/m2/course IV over 2 hours on days -4, -3, -2 or busulfan 12 mg/kg/course PO on days -4, -3, -2 or total body irradiation (TBI) 12 Gy/course on days -4, -3, -2.
TRANSPLANT: Patients undergo allogeneic G-CSF mobilized CD3-depleted peripheral blood stem cell transplantation on day 0.
PHARMACOLOGIC GVHD PROPHYLAXIS: Patients receive tocilizumab 8 mg/kg on day -1 and abatacept 10 mg/kg/day IV over 1 hour on days -1, +7, +14 and +28 (the last one - only in case of haploidentical donor).
DONOR NK-CELL INFUSIONS: Each patient is planned to receive two mbIL21 ex vivo-expanded donor-derived NK-cell infusions. Escalating doses of NK-cells (CD3-CD56+) to be infused in the Phase I study as follows:
- Level 1: 10х106/kg
- Level 2: 20х106/kg
- Level 3: 30х106/kg In case of level 1 dose is not tolerated, an additional dose level (Level 0 - 5х106/kg) can be added. In the absence of unacceptable toxicity level 1 dose further can be used.
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.
To be able to receive NK-cell infusion patient must fulfil the following clinical criteria:
- Off corticosteroids more than 0,5 mg/kg/day prednisone or equivalent within prior 72 hours period;
- No uncontrolled infection within 24 hours;
- No grade 3 or greater nonhematologic adverse reactions (only for the second NK-cell infusion);
- Not requiring ventilator support or more than 5 L/min of supplemental oxygen. DONOR SELECTION CRITERIA: In case of detection of two or more suitable donors, besides standart donor selection criteria (CMV serology, sex, blood group etc.) the choice will be made in favor of the presence of KIR-ligand mismatch.
DURATION OF THERAPY: 21 day (14 days before HSCT and up to 7 days after HSCT). Follow up during 2 years after HSCT.
CRITERIA FOR PREMATURE STOPPING OF THE STUDY: DLT in 2 patients of expanded cohort with a minimum (Level 0) dose level. DLT is defined as associated with the intervention immune-related adverse event (cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome) grade 3 or higher according to ASTCT criteria.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic T-cell Leukemia, Mixed Phenotype Acute Leukemia
- Being tested
- Donor-derived Natural Killer Cell
- Keywords
- Natural killer cell therapy, Hematopoietic stem cell transplantation, Leukemia, Acute, Refractory Leukemias, Pre-transplantation MRD-positivity
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor-derived Natural Killer CellBiological
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 group | Role | What they receive |
|---|---|---|
| Biological: Donor-derived Natural Killer Cell Infusions | Experimental | Not described Receives: Biological: Donor-derived Natural Killer Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who received the planned dose of NK cells without adverse reactions grade ≥3 according to CTCAE v5.0
Measured: 180 days from the last administration of donor NK cells
Secondary outcomes (7)
Rate of morphologic bone marrow leukemia-free state
Rate of morphologic bone marrow leukemia-free state on day -4, morphologic complete remission on day +30 (only for patients with chemorefractory acute leukemia).
Measured: on day -4 before HSCT, and +30 days after HSCT
Rate of MRD-negativity
Measured: on days -4 before HSCT and +30 days after HSCT
Cumulative incidence of developing acute graft-versus-host disease
Measured: 180 days from the last administration of donor NK cells
Cumulative incidence of relapse
Measured: 2 years after allo-HSCT
Cumulative incidence of transplantation-related mortality
Measured: 100 days and 2 years after allo-HSCT
Probability of engraftment
Measured: 30 days after allo-HSCT
Overall survival
Measured: 2 years after allo-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start9 May 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256210
- Sponsor's protocol ID
- NDGOI-11-2024
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07256210
- Acronym / sponsor ID
- NDGOI-11-2024
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic T-cell Leukemia, Mixed Phenotype Acute Leukemia
- Keywords
- Natural killer cell therapy, Hematopoietic stem cell transplantation, Leukemia, Acute, Refractory Leukemias, Pre-transplantation MRD-positivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale. In the context of treating children and young adults with high-risk or chemorefractory acute leukemia allogeneic hematopoietic stem cell transplantation (allo-HSCT) plays a crucial role. It is well known, that residual tumor cell volume at the time of allo-HSCT has a significant impact on its outcomes. The antileukemic effect of allo-HSCT in some hematologic malignancies is predominantly mediated by graft-versus-leukemia effect, which is an immune-mediated reaction of engrafted donor hematopoiesis against the recipient's tumor cells. The graft-versus-leukemia effect is generally ascribed to NK-cells conserved within the graft or arising from it early after transplantation.
Primary objective: to evaluate feasibility, safety and to identify the maximum tolerated dose (MTD) of mbIL21 ex vivo-expanded donor-derived NK-cell cells to be infused to children and young adults aged 1 to 25 years with chemorefractory or pre-transplant MRD-positive acute leukemia undergoing allo-HSCT.
Secondary objectives:
- To assess the short-term disease response to NK cell infusions as an adjunct to allo-HSCT.
- To assess the impact of NK cell infusions on reconstitution of main lymphocyte subpopulations in allo-HSCT recipients.
- To assess the impact of NK cell infusions on main allo-HSCT outcomes. Outline. This is a phase I, 3+3 dose-escalation study of NK-cells followed by a phase II study. Conditioning regimen will be split into two parts. Two donor NK-cell infusions will be carried out: after the first part of conditioning and early after transplant.
FIRST PART OF CONDITIONING: Patients receive fludarabine 40 mg/m2/day IV over 1 hour on days -14 and -13, thiotepa 10 mg/kg/course IV over 1 hour on days -14 and -13 and cyclophosphamide 500 mg/m2 IV over 1 hour on day -14.
SECOND PART OF CONDITIONING: Patients receive fludarabine 40 mg/m2/day IV over 1 hour on days -4 and -3, treosulfan 42 g/m2/course IV over 2 hours on days -4, -3, -2 or busulfan 12 mg/kg/course PO on days -4, -3, -2 or total body irradiation (TBI) 12 Gy/course on days -4, -3, -2.
TRANSPLANT: Patients undergo allogeneic G-CSF mobilized CD3-depleted peripheral blood stem cell transplantation on day 0.
PHARMACOLOGIC GVHD PROPHYLAXIS: Patients receive tocilizumab 8 mg/kg on day -1 and abatacept 10 mg/kg/day IV over 1 hour on days -1, +7, +14 and +28 (the last one - only in case of haploidentical donor).
DONOR NK-CELL INFUSIONS: Each patient is planned to receive two mbIL21 ex vivo-expanded donor-derived NK-cell infusions. Escalating doses of NK-cells (CD3-CD56+) to be infused in the Phase I study as follows:
- Level 1: 10х106/kg
- Level 2: 20х106/kg
- Level 3: 30х106/kg In case of level 1 dose is not tolerated, an additional dose level (Level 0 - 5х106/kg) can be added. In the absence of unacceptable toxicity level 1 dose further can be used.
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.
To be able to receive NK-cell infusion patient must fulfil the following clinical criteria:
- Off corticosteroids more than 0,5 mg/kg/day prednisone or equivalent within prior 72 hours period;
- No uncontrolled infection within 24 hours;
- No grade 3 or greater nonhematologic adverse reactions (only for the second NK-cell infusion);
- Not requiring ventilator support or more than 5 L/min of supplemental oxygen. DONOR SELECTION CRITERIA: In case of detection of two or more suitable donors, besides standart donor selection criteria (CMV serology, sex, blood group etc.) the choice will be made in favor of the presence of KIR-ligand mismatch.
DURATION OF THERAPY: 21 day (14 days before HSCT and up to 7 days after HSCT). Follow up during 2 years after HSCT.
CRITERIA FOR PREMATURE STOPPING OF THE STUDY: DLT in 2 patients of expanded cohort with a minimum (Level 0) dose level. DLT is defined as associated with the intervention immune-related adverse event (cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome) grade 3 or higher according to ASTCT criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological: Donor-derived Natural Killer Cell Infusions | Experimental | Biological: Donor-derived Natural Killer Cell |
Who may qualify
- Ages
- 1 month to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Patient (age from 14 to 25 years) and/or patient's legal representative (age from 0 to 18 years) should provide written informed consent.
- Patients with one of the following disease:
- Patient is indicated to receive allo-HSCT according to actual clinical practice.
- Haploidentical or matched related donor was chosen and is available for allo-HSCT (and NK-cell therapy).
- Patient's clinical status: Lansky/Karnowski index ≥50%.
Key exclusion criteria (7 listed)
- Inability to provide or withdrawal of written informed consent.
- Cellular therapy including allo-HSCT within prior 4 months period, absence of active signs of GVHD, sinusoidal obstruction syndrome, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome.
- Active hepatitis B, C or HIV infection.
- Pregnant or lactating women.
- Uncontrolled infection; principal investigator is the final arbiter of this criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor-derived Natural Killer CellThese 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. | Biological | Biological: Donor-derived Natural Killer Cell Infusions |
Primary outcome
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
7 secondary outcomes
Rate of morphologic bone marrow leukemia-free state
Time frame: on day -4 before HSCT, and +30 days after HSCT
Rate of MRD-negativity
Time frame: on days -4 before HSCT and +30 days after HSCT
Cumulative incidence of developing acute graft-versus-host disease
Time frame: 180 days from the last administration of donor NK cells
Cumulative incidence of relapse
Time frame: 2 years after allo-HSCT
Cumulative incidence of transplantation-related mortality
Time frame: 100 days and 2 years after allo-HSCT
Probability of engraftment
Time frame: 30 days after allo-HSCT
Overall survival
Time frame: 2 years after allo-HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donor-derived Natural Killer Cell in people with Acute Myeloid Leukemia and Acute Lymphoblastic T-cell Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timofei Y Zavidnyi, MD (+79153492188, timofey.zavidnyy@dgoi.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.