NCT06892223 Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
| NCT ID | NCT06892223 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Acute Myeloid Leukaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2021-12-03 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2021-12-03 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related procedures. 2. Adult patients aged ≥18 years old, without any restriction of gender and race. 3. Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN). 4. Patients lacking a HLA identical donor and 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. 5. Patient who has received 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. 6. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 8 days prior to start of study drug for women of childbearing potential. 7. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception. Exclusion Criteria: 1. Patients aged \< 18 years old. 2. Active uncontrolled infections. 3. CNS involvement of AML disease. 4. Karnofsky performance status (KPS) \<60% or severe organ dysfunction, including a left ventricular ejection fraction \<40%, DLCO \<50% or creatinine clearance \<50 ml/min (as per transplant eligibility). 5. Pregnant or breast-feeding or intending to become pregnant during the study. 6. Patients who rapidly relapse after allogenic-SCT before day 30 after allogenic-SCT. 7. Patients who experience acute GVHD before day +30 after allogenic-SCT. 8. Patients treated with a second allogeneic Allo-SCT.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06892223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Acute Myeloid Leukaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06892223 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06892223 currently recruiting?
Yes, NCT06892223 is actively recruiting participants. Contact the research team at domenico.mavilio@humanitas.it for enrollment information.
Where is the NCT06892223 trial being conducted?
This trial is being conducted at Genova, Italy, Rozzano, Italy.
Who is sponsoring the NCT06892223 clinical trial?
NCT06892223 is sponsored by Istituto Clinico Humanitas. The trial plans to enroll 42 participants.