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OncoMatch/Clinical Trials/NCT06892223

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

Is NCT06892223 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Monalizumab (anti-NKG2A monoclonal antibody) for acute myeloid leukaemia.

Phase 2RecruitingIstituto Clinico HumanitasNCT06892223Data as of Jun 2026Location: Italy

Treatment: Monalizumab (anti-NKG2A monoclonal antibody)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

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Extracted eligibility criteria

Treatments studied

Other

Monalizumab (anti-NKG2A monoclonal antibody)

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Myeloproliferative Neoplasm

Demographics

Ages ≤ 99

Prior therapy

Must have received: haploidentical stem cell transplant

receiving haploidentical stem cell transplant with GVHD/HVG prophylaxis consisting of Cyclophosphamide: 40 or 50 mg/kg/day, day +3 and +4, Cyclosporine A: 3 mg/kg/day from day +5, Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35

Must have received: myeloablative or reduced intensity or nonmyeloblative conditioning followed by bone marrow or PBSC graft

haplo-SCT with a myeloablative or reduced intensity or nonmyeloblative conditioning followed, either by a bone marrow or a peripheral blood stem cell (PBSC) graft

Cannot have received: second allogeneic stem cell transplant

Patients treated with a second allogeneic Allo-SCT

Lab requirements

Kidney function

creatinine clearance <50 ml/min (as per transplant eligibility)

Cardiac function

left ventricular ejection fraction <40%

severe organ dysfunction, including a left ventricular ejection fraction <40%, DLCO <50% or creatinine clearance <50 ml/min (as per transplant eligibility)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06892223 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior second allogeneic stem cell transplant disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 99 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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