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Acute Myeloid LeukemiaNCT06885476

Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients

A study testing Infusion of alloreactive NK cells in people with Acute Myeloid Leukemia and Minimal Residual Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a interventional, transplantation study. The procedure under study is the infusion of alloreactive NK cells in adult AML patients, eligible for ASCT, who achieved CR after conventional chemotherapy, but harbor MRD-positivity. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Infusion of alloreactive NK cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteItaly
Study dates
22 Jan 2021to Dec 2026
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of de novo or secondary AML
  • Age ≥ 18 years
  • Morphologic CR
  • Eligibility for ASCT
  • MRD-positivity after induction chemotherapy
  • Availability of a KIR-L incompatible haploidentical donor
Show all 10Show fewer
  • Performance Status ≥ 70% (Karnofsky score) or ≤ 2 (WHO).
  • Adequate renal (serum creatinine < 2 mg/dl), pulmonary (Sat O2 ≥ 96%) and hepatic (ALT/AST < 2.5 x N) function.
  • Left Ventricular Ejection Fraction (LVEF) of >50% as determined by Echocardiogram (ECHO).
  • Signed informed consent.

Who cannot join

  • Diagnosis of AML FAB M3
  • HIV positivity.
  • HCV positivity with high viral load.
  • Pregnant or nursing females.
  • Current uncontrolled infection.
  • Signs or symptoms of fluid retention (e.g. pleural effusion).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio Curti contact

+390512144074

antonio.curti2@unibo.it

Italy1 site, 1 recruiting

  • Antonio Curti

    Bologna, BO, 40138

    Antonio Curti, +390512144074, antonio.curti2@unibo.it

    Recruiting

Other trials in Italy

About this study

Official title: Infusion of Alloreactive nk Cells for Acute Myeloid Leukemia Patients, Eligible for Allogeneic Stem Cell Transplantiation, With Persistent Minimal Residual Disease After Conventional Chemotherapy

This is a interventional, transplantation study. The procedure under study is the infusion of alloreactive NK cells in adult AML patients, eligible for ASCT, who achieved CR after conventional chemotherapy, but harbor MRD-positivity.

Haploidentical KIR-L mismatched donors will be included if present at least one allele mismatch at a class I locus among the following ones: HLA-C alleles with Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles. KIR-L mismatched donor alloreactive NK cell repertoire will be evaluated in order to determine the functional cell dose to be used for NK cell collection. Phenotypical analysis of KIRs will be correlated to functional tests. NK cells will be selected from a steady-state large volume leukapheresis product from a suitable haploidentical KIR-ligand incompatible donor. NK cell purification will be performed if the donor leukapheresis product contains at least 10x106 NK cells/Kg.

Read more

Immunomagnetic enrichment of NK cells will follow two subsequent steps: 1) depletion of CD3+ T cells followed by 2) positive selection of CD56+ NK cells.

Patients will receive immunosuppressive chemotherapy, fludarabine (Flu) 25 mg/mq/ from day -5 to -3 and cyclophosphamide (Cy) 2 g/mq on day -2 (Flu/Cy). Two days after Cy administration, patients will be infused intravenously with a single dose of cryopreserved NK cells (day 0), which will be followed by subcutaneous administration of IL-2 (10 x 106 IU/day, 3 times weekly) for 2 weeks (6 doses total). PB samples will also be collected for biological studies. In particular, PB samples will be collected for molecular assessment of microchimerism and tracking of haploidentical NK cells for 30 days, immunophenotype studies, alloreactive NK cells cloning and functional assays (cytotoxicity). Enrolled patients will be followed up for at least 12 months after NK cell infusion.

Being tested
Infusion of alloreactive NK cells
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion of alloreactive NK cellsBiological

    Infusion of alloreactive NK cells for acute leukemia patients harboring minimal residual disease after conventional chemotherapy and prior to allogeneic stem cell transplantation

Study groups in NCT06885476
Study groupRoleWhat they receive
Infusion of alloreactive NK cellsExperimentalInfusion of alloreactive NK cells for acute leukemia patients, eligible for allogeneic stem cell transplantation, with persistent minimal residual disease after conventional chemotherapy
Receives: Biological: Infusion of alloreactive NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of infusing a functional target cell dose of 2x105 alloreactive NK cells/kg in AML patients,eligible for ASCT, with persistent MRD after conventional chemotherapy

    Safety of infusing a functional target cell dose of 2x105 alloreactive NK cells/kg in AML patients,eligible for ASCT, with persistent MRD after conventional (number of adverse events and severe adverse events)

    Measured: 48 months

  2. Feasibility of collecting a functional target cell dose of 2x105 alloreactive NK cells/kg in at least 70% of patients entering the study

    Feasibility of collecting a functional target cell dose of 2x105 alloreactive NK cells/kg in at least 70% of patients entering the study as evaluated by in vitro cytotoxicity assay.

    Measured: 48 months

Secondary outcomes (9)

  1. Number of patients who achieve and maintain MRD negativity after infusion of alloreactive NK cells

    Number of patients who achieve and maintain MRD negativity after infusion of alloreactive

    Measured: 48 months

  2. Number of patients who enter ASCT in MRD-negativity

    Number of patients who enter ASCT in MRD-negativity

    Measured: 48 months

  3. Relapse-free survival (RFS) of patients infused with alloreactive NK cells

    Relapse-free survival (RFS)of patients infused with alloreactive NK cells

    Measured: 48 months

  4. overall survival (OS) of patients infused with alloreactive NK cells

    overall survival (OS) of patients infused with alloreactive NK cells

    Measured: 48 months

  5. Assess the predictive impact of donor NK cell repertoire on overall survival

    Assess the predictive impact of donor NK cell repertoire as evaluated as the number of alloreactive NK cells/kg, in terms of overall survival

    Measured: 48 months

  6. Assess the predictive impact of donor NK cell repertoire on relapse-free survival

    Assess the predictive impact of donor NK cell repertoire as evaluated as the number of alloreactive NK cells/kg, in terms of relapse-free survival

    Measured: 48 months

  7. Evaluate the microchimerism of patients receiving human NK cells

    Evaluate the microchimerism of patients receiving human NK cells, as evaluated as percent of donor's cells into recipients

    Measured: 48 months

  8. Functionally evaluate, in vitro and ex vivo, the antitumor activity of infused NK cells

    Functionally evaluate, in vitro and ex vivo, the antitumor activity of infused NK cells, as evaluated by in vitro cytotoxicity assay (percent of lysis by donor NK cells of recipients cells).

    Measured: 48 months

  9. Assess the molecular features of infused NK cells

    Assess the molecular features of infused NK cells, qualitative gene expression profile.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start22 Jan 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885476
Sponsor's protocol ID
MRD-NK
Status last verified
Apr 2024
First submitted
22 Jan 2021
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Infusion of alloreactive NK cells in people with Acute Myeloid Leukemia and Minimal Residual Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

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 10 inclusion and 6 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 20 Mar 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 Italy. 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.

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 Antonio Curti (+390512144074, antonio.curti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of infusing a functional target cell dose of 2x105 alloreactive NK cells/kg in AML patients,eligible for ASCT, with persistent MRD after conventional chemotherapy (time frame: 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885476.

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 20 Mar 2025.

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