EUCTR2019-003686-17-FR进行中（未招募）1 期
A prospective phase I/IIa, open-label, multicentre trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in subjects with acute myeloid leukaemia who are in complete morphologic remission with measurable residual disease and without a strong indication for stem cell transplantation.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible to participate in this trial, subjects must meet ALL of the following eligibility criteria:
- •1.Male or female subjects = 18 years old
- •2.Subjects with a diagnosis of AML and related precursor neoplasms according to the WHO 2016 classification (excluding acute promyelocytic leukaemia), including secondary AML after an antecedent haematological disease (e.g. myelodysplastic syndrome) and therapy-related AML
- •3.Subjects who have achieved CMR, including CRi and complete clinical remission, with MRD documented at screening, as assessed by centralized MFC, after one or two courses of remission induction chemotherapy and who have completed consolidation chemotherapy or who achieved CMR with documented MRD with hypomethylating agents or other relevant appropriate therapies
- •4.Life expectancy = 6 months at screening
- •5.Adequate renal and hepatic functions within 14 days of study screening, unless clearly disease related, as indicated by the following laboratory values:
- •a.Serum creatinine = 3 times the upper limit of normal (ULN) and estimated glomerular filtration rate (eGFR) = 30 ml/min/1.73m2
- •b.Serum total bilirubin < 2.0 mg/dl, unless due to Gilbert’s syndrome
- •c.Alanine transaminase (ALT) = 2.5 x ULN
- •6.Karnofsky Status = 50%
- •7.Male subjects with partners who are women of childbearing potential must use an effective contraceptive method during the trial and for a minimum of 6 months after trial treatment, or have undergone successful vasectomy at least 6 months prior to entry into the trial (confirmed by semen analysis).
- •8.Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use an effective contraceptive method during the trial and for a minimum of 6 months after trial treatment.
- •9.Able and willing to provide written informed consent and comply with the study protocol and procedures
- •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 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Subjects who meet any of the following criteria at screening will be excluded from trial entry:
- •1.Subjects proceeding to allogeneic HSCT, i.e. subject is a suitable candidate for allogeneic HSCT and donor is expected to be available in a timely manner
- •2.Subjects having received prior allogeneic HSCT
- •3.Subjects with acute promyelocytic leukaemia
- •4.Diagnosis of any previous or concomitant malignancy is an exclusion criterion, except when the subject completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to enrolment
- •5.Blast crisis of chronic myeloid leukaemia
- •6.Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)
- •7.Antibodies against HLA (anti-HLA) present
- •8.Seronegativity for Epstein-Barr Virus (EBV)
- •9.Known allergy to any of the components of oNKord® (e.g., dimethyl sulfoxide [DMSO]) or to any of the drugs to be administered in the preparative regimen to oNKord® infusion
- •10.Contraindication to any of the drugs to be administered in the conditioning regimen or oNKord® infusion. This includes Cy, Flu, and medications associated with prophylaxis of AEs
- •11.Cardiac dysfunction as defined by:
- •a.Myocardial infarction within the last 3 months of trial entry, or
- •b.Reduced left ventricular function with an ejection fraction < 40% as measured by multi-gated acquisition (MUGA) scan or echocardiogram (echo) within 28 days before screening, or
- •c.Unstable angina, or
- •d.New York Heart Association (NYHA) Class IV congestive heart failure, or
- •e.Unstable cardiac arrhythmias
- •12.Pulmonary dysfunction as defined by oxygen saturation < 90% on room air. Pulmonary function test (PFT) is required only in the case of symptomatic or prior known impairments within 28 days before screening - with pulmonary function < 50% corrected diffusing capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in 1 second (FEV1)
- •13.Major surgery within 4 weeks prior to screening or a major wound that has not fully healed
- •14.Vaccination with live, attenuated vaccines within 4 weeks prior to screening
- •15.Immunosuppressive drugs for concomitant disease. Subject must be able to be off prednisone or other immunosuppressive medications for at least 3 days prior to the start of Cy/Flu regimen
- •16.History of stroke or intracranial haemorrhage within 6 months prior to screening
- •17.Active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to trial treatment
- •18.History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •19.Current concomitant chemotherapy, radiation therapy, or immunotherapy
- •20.Positive pregnancy test or breastfeeding for women of childbearing potential
- •21.Participation in another interventional clinical trial within 4 weeks prior to trial enrolment or participation in a concomitant interventional clinical trial
- •22.Any serious concomitant medical condition, medication or therapy which could, in the opinion of the Investigator, compromise participation in the trial
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