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Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation

NCT06892223 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-03-24

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of the anti-NKG2A monoclonal antibody (Monalizumab) in patients undergoing haploidentical stem cell transplantation (Haplo-SCT) with post-transplantation cyclophosphamide (PT-Cy). The main questions this trial aims to answer are:

* Does Monalizumab improve graft-versus-host disease-free and progression-free survival (GPFS) in patients after Haplo-SCT?
* What are the safety and side effects of Monalizumab in this patient group?
* How does Monalizumab affect the reconstitution and function of NK cells in patients undergoing Haplo-SCT?
* Researchers will administer Monalizumab to participants on day +30 and +44 after transplantation to see if it enhances immune responses and prevents disease relapse or GVHD.

Participants will:

* Receive Monalizumab intravenously at 1 mg/kg on day +30 and day +44 after Haplo-SCT
* Be monitored for clinical outcomes such as GVHD, survival rates, and immune function for up to one year after the transplant
* Undergo regular checkups and tests to assess the effectiveness and safety of the treatment

Conditions

  • Acute Myeloid Leukaemia
  • MDS (Myelodysplastic Syndrome)
  • MPN (Myeloproliferative Neoplasms)

Interventions

DRUG

Monalizumab (anti-NKG2A monoclonal antibody)

Monalizumab (humZ270 mAb, IPH2201) is a humanized IgG4 monoclonal antibody targeting the NKG2A receptor on NK cells. Administered intravenously at a dose of 1 mg/kg on days +30 and +44 after haploidentical stem cell transplantation with post-transplant cyclophosphamide (PT-Cy) as GVHD prophylaxis, Monalizumab aims to enhance NK cell activity by blocking NKG2A. This intervention is unique in its timing, as it is given during a period when CD94/NKG2A+ NK cells are abundant, and its two-dose regimen is designed to optimize NK cell reconstitution. It targets patients with hematologic malignancies, such as AML and MDS, to improve GVHD-free and progression-free survival by enhancing NK cell-mediated immunity. This approach differs from other therapies by focusing on NK cell alloreactivity in the post-transplant setting. Cyclophosphamide is used as part of the pre-transplant conditioning regimen and is part of the inclusion criteria, but it is not part of the protocol-specific intervention.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2025-03-01
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892223 on ClinicalTrials.gov