Monalizumab treatment for patients with blood cancers undergoing stem cell transplantation
Phase II Clinical Trial to Optimize the Dose of an Anti-NKG2A Monoclonal Antibody (humZ270 MAb, IPH2201) for Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Haploidentical Transplantation with Post- Transplantation Cyclophosphamide
This study is testing if a new treatment called Monalizumab can help people with blood cancers like AML or MDS who are getting stem cell transplants by improving their immune response and reducing the chances of disease returning or complications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | Cyclophosphamide, Monalizumab |
| Locations | 2 sites (Genova, GENOVA and 1 other locations) |
| Trial ID | NCT06892223 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of Monalizumab, an anti-NKG2A monoclonal antibody, in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) undergoing haploidentical stem cell transplantation. Participants will receive Monalizumab intravenously on specific days post-transplantation and will be monitored for outcomes such as graft-versus-host disease (GVHD) and progression-free survival. The study aims to enhance immune responses and reduce the risk of disease relapse or GVHD by optimizing the use of this novel antibody.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with AML or MDS who are undergoing haploidentical stem cell transplantation and lack an HLA identical donor.
Not a fit: Patients with fully matched donors or those not undergoing haploidentical stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients undergoing stem cell transplantation for blood cancers.
How similar studies have performed: Preclinical studies have shown promise for similar approaches using anti-NKG2A antibodies, indicating potential for success in this clinical setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Genova, GENOVA and 1 other locations
- IRCCS Ospedale Policlinico San Martino — Genova, Genova, Italy (Recruiting)
- Irccs Istituto Clinico Humanitas — Rozzano, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Domenico Mavilio, Md
- Email: domenico.mavilio@humanitas.it
- Phone: +39 02 8224 5157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.