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

Sponsor
Istituto Clinico Humanitas
Study ID
NCT06892223
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Monalizumab (anti-NKG2A monoclonal antibody) — DRUG
    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.

Study Details

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

Key Dates

Start date
Dec 3, 2021
Status verified
Mar 2025
Primary completion
Mar 1, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: monalizumab treatment arm
    This study includes a single arm, where all patients will receive Monalizumab (humZ270 mAb, IPH2201), an anti-NKG2A monoclonal antibody, as the intervention. Monalizumab is administered intravenously at a dose of 1 mg/kg on day +30 and day +44 after undergoing haploidentical stem cell transplantation (Haplo-SCT). The use of post-transplantation cyclophosphamide (PT-Cy) is part of the conditioning regimen and inclusion criteria but is not part of the protocol-specified intervention. Monalizumab aims to enhance the immune function of NK cells by blocking the NKG2A receptor, potentially improving graft-versus-host disease (GVHD)-free and progression-free survival (GPFS).

Primary Outcome Measure

Graft-versus-host disease-free and progression-free survival (GPFS) [ Time Frame: GPFS will be evaluated 1 year after Haplo-SCT with PT-Cy and Monalizumab administration on day +30 and +44. ]

Central Contacts

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