Actively Recruiting
Phase II Trial to Optimize Dose of Anti-NKG2A Monoclonal Antibody (Monalizumab) for AML or MDS Patients Undergoing Haploidentical Transplant with Post-Transplant Cyclophosphamide
Led by Istituto Clinico Humanitas · Updated on 2025-03-24
42
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Monalizumab, an anti-NKG2A monoclonal antibody, in adults with blood cancers such as Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are undergoing haploidentical stem cell transplantation (Haplo-SCT) with post-transplant cyclophosphamide (PT-Cy). This Phase II, open-label, single-arm study aims to improve outcomes by enhancing natural killer (NK) cell activity to reduce graft-versus-host disease (GVHD) and disease relapse. The trial focuses on assessing graft-versus-host disease-free and progression-free survival (GPFS) one year after transplantation and monitoring safety and immune function effects of Monalizumab.
CONDITIONS
Brief Title
Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and willing to follow study procedures
- Adults aged 18 years or older
- Diagnosed with Acute Myeloid Leukemia, Myelodysplastic Syndrome, or MDS/MPN
- Receiving haploidentical stem cell transplant with GVHD prophylaxis including cyclophosphamide, cyclosporine A, and mycophenolate mofetil
- Have undergone myeloablative, reduced intensity, or nonmyeloablative conditioning followed by bone marrow or peripheral blood stem cell graft
- Negative pregnancy test for women of childbearing potential within 8 days before study drug
- Women of childbearing potential and men with female partners agree to use effective contraception during and for 52 weeks after study therapy
You will not qualify if you...
- Under 18 years of age
- Have active uncontrolled infections
- Central nervous system involvement of AML
- Karnofsky performance status below 60% or severe organ dysfunction such as low heart function, low lung capacity, or poor kidney function
- Pregnant, breastfeeding, or planning to become pregnant during the study
- Rapid relapse after allogeneic stem cell transplant before day 30
- Experience acute graft-versus-host disease before day 30 post-transplant
- Have received a second allogeneic stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From day +30 to day +44 post-transplant
Participants receive two intravenous infusions of Monalizumab at 1 mg/kg on days +30 and +44 after haploidentical stem cell transplantation with post-transplant cyclophosphamide. This treatment aims to enhance natural killer cell activity and improve survival outcomes.
2 visits (in-person) for antibody infusions
Duration - Up to 1 year after transplantation
Participants are monitored for graft-versus-host disease, progression-free survival, overall survival, and post-transplant viral infections for up to one year after transplantation.
Regular visits with assessments at 6 months and 1 year post-transplant
Trial Site Locations
Total: 2 locations
1
IRCCS Ospedale Policlinico San Martino
Genova, GENOVA, Italy, 16132
Actively Recruiting
2
Irccs Istituto Clinico Humanitas
Rozzano, MILANO, Italy, 20089
Actively Recruiting
Research Team
D
DOMENICO MAVILIO, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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