OncoMatch/Clinical Trials/NCT06892223
Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
Is NCT06892223 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Monalizumab (anti-NKG2A monoclonal antibody) for acute myeloid leukaemia.
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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
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.
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