Clinical trial · Interventional
Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS (Myelodysplastic Syndrome) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| MPN (Myeloproliferative Neoplasms) | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monalizumab (anti-NKG2A monoclonal antibody) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- monalizumab treatment arm
- description
- This study includes a single arm, where all patients will receive Monalizumab (humZ270 mAb, IPH2201), an anti-NKG2A monoclonal antibody, as the intervention. Monalizumab is administered intravenously at a dose of 1 mg/kg on day +30 and day +44 after undergoing haploidentical stem cell transplantation (Haplo-SCT). The use of post-transplantation cyclophosphamide (PT-Cy) is part of the conditioning regimen and inclusion criteria but is not part of the protocol-specified intervention. Monalizumab aims to enhance the immune function of NK cells by blocking the NKG2A receptor, potentially improving graft-versus-host disease (GVHD)-free and progression-free survival (GPFS).
- interventionNames
- Drug: Monalizumab (anti-NKG2A monoclonal antibody)
Primary outcomes (1)
- measure
- Graft-versus-host disease-free and progression-free survival (GPFS)
- timeFrame
- GPFS will be evaluated 1 year after Haplo-SCT with PT-Cy and Monalizumab administration on day +30 and +44.
- description
- GPFS is defined as the time from Haplo-SCT with post-transplant cyclophosphamide (PT-Cy) until the occurrence of either graft-versus-host disease (GVHD) or disease progression/relapse. This measure evaluates the combined effect of Monalizumab (NKG2A blockade) in preventing both GVHD and disease progression. It is a comprehensive indicator of treatment efficacy, assessing whether the addition of Monalizumab improves patient outcomes by prolonging the period free of both GVHD and disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available