An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients. - DEPLETHINK – LymphoDEPLEtion and THerapeutic Immunotherapy with NKR-2

Celyad Onclogy SA0 个研究点目标入组 17 人开始时间: 2018年2月21日最近更新: 2021年12月13日

适应症

试验速览

暂无简介。

•1) Men or women = 18 and = 75 years old at the time of signing the Informed Consent Form (ICF).
•2) The patient is not eligible for standard of care therapy and must have one of the following hematological malignancy:
•- A confirmed relapsed or refractory acute myeloid leukemia (AML) (i.e. = 5% blasts in bone marrow or in peripheral blood) after at least one prior therapy.
•- A confirmed myelodysplastic syndrome (MDS) with revised International Prognostic Scoring System (R-IPSS) criteria for Intermediate, High-risk or Very High-risk disease or refractory anemia with excess blasts by WHO (i.e. = 5% blasts in bone marrow or = 2% blasts in peripheral blood) or MDS with TP53 mutation as detected by next-generation sequencing (NGS).
•3) The absolute peripheral blast count should be < 15,000/µL.
•4) The patient must have an ECOG performance status =2.
•5) The patient must have sufficient hepatic and renal functions,.
•6) Ejection fraction of = 40%.
•7)Patients must have sufficient pulmonary functions with a Forced Expiratory Volume in the first second (FEV-1)/Forced Vital Capacity (FVC) = 0.7 with FEV-1 = 50% predicted.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1) Patient presenting with history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease (COPD).
•2) Patient that received any cancer therapy within 2 weeks before the planned day for the apheresis (with the exception of hydroxyurea).
•3) Patients receive, concurrently receive, or have received any investigational agent within 3 weeks before the planned day for the first NKR-2 administration (except for hydroxyurea).
•4) Patient is under systemic immunosuppressive drugs, unless specific cases authorized per protocol.
•5) Patients have received prior allogeneic stem cell transplantation or chimeric antigen receptor therapy.

发起方

Celyad Onclogy SA