2024-516974-31-00招募中2 期
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.
Humanitas Mirasole S.p.A.2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy and safety of NKG2A blockade by Monalizumab after Haplo-SCT with PTCy in terms of GPFS.
研究概览
简要总结
Evaluate the efficacy and safety of Monalizumab after Haplo-SCT with PT-Cy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related procedures.
- •Adult patients aged =18 yearsold, without any restriction of gender and race.
- •Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN).
- •Patients lacking a human leukocyte antigen (HLA) identical donor and receiving Haplo- SCT with GVHD/host versus graft (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 +
- •Patient who have received Haplo-SCT with a myeloablative (MA) or reduced intensity (RIC) or non-myeloblative (NMA) conditioning followed either by a bone marrow or a peripheral blood stem cell (PBSC) graft.
- •Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
- •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.
排除标准
- •Patients aged <
- •Active uncontrolled infections.
- •Central nervous system (CNS) involvement of AML disease.
- •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).
- •Pregnant or breast-feeding or intending to become pregnant during the study.
- •Patients who rapidly relapse after allogenic-SCT before day 30 after Haplo-SCT.
- •Patients who experience acute GVHD before day +30 after Haplo-SCT.
- •Patients treated with a second allogeneic Allo-SCT.
结局指标
主要结局
To evaluate the efficacy and safety of NKG2A blockade by Monalizumab after Haplo-SCT with PTCy in terms of GPFS.
To evaluate the efficacy and safety of NKG2A blockade by Monalizumab after Haplo-SCT with PTCy in terms of GPFS.
次要结局
- Clinical Objectives: Evaluate the incidence of OS, PFS, NRM and post-transplant viral infections in patients receiving Monalizumab after Haplo-SCT.
- Biological Objectives: Evaluate the reconstitution and alloreactive functions of NK cell population against leukemic cells after Monalizumab administration.
研究者
Immunologia Clinica
Scientific
Humanitas Mirasole S.p.A.
研究点 (2)
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