CTIS2023-505259-39-00招募中1 期
A phase 1/2a, first-in-human, open-label, multicenter, dose escalation study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) - MP0533-CP101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Has signed and dated written informed consent prior to performing any study procedure, including screening, Diagnosis of relapsed/refractory AML or relapsed/refractory MDS/AML according to the ELN recommendation 2022, Age =18 years old on the day of signing informed consent, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2, Anticipated life expectancy = 12 weeks by investigator judgement, Adequate renal and hepatic function: a. Creatinine clearance > 40 mL/min on the basis of Cockcroft-Gault glomerular filtration rate estimation, unless considered AML- or MDS-related b. Serum bilirubin = 2.5 x upper limit of normal (ULN), unless considered AML- or MDS-related or due to Gilbert’s syndrome c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 x ULN, unless considered AML- or MDS-related, White blood count (WBC) = 15G/L at day of trial drug infusion (prior hydroxyurea allowed), s using highly effective contraception, for females of childbearing potential (FCBP) and for men.
排除标准
- •Mixed phenotype acute leukemia, Allogeneic HCT within the last 3 months prior to start of trial medication and/or eligibility for standard 2nd line of targeted therapy, like gilteritinib for FLT3 mutated AML, unless this therapeutic option has already been given and proven ineffective (patient relapsed or resistant to), or contraindicated, or confounding mutations exist, or there is a lack of access to this recommended therapy., Known hypersensitivity to any of the excipients of the investigational medicinal product (IMP), i.e. finished MP0533 drug, Any condition that, in the opinion of the investigator, would interfere with evaluation of the IMP or interpretation of the patient’s data, Unable or unwilling to comply with all study requirements for clinical visits, examinations, tests and procedures, and contraception requirements, Patient deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency, Active GvHD requiring immune-suppressive therapy (other than prednisone (or equivalent) = 10mg/d), Use of immunosuppressive drugs (other than prednisone (or equivalent) =10mg/d) in the past 4 weeks, Clinical signs of AML in the central nervous system, Major surgery within 28 days prior to start of study medication, Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed, Left ventricular ejection fraction of < 50% on echocardiographic exam at screening, Any uncontrolled active infection, Treatment with investigational agents or agents targeting CD33, CD123 or CD70 within 4 weeks or five times the half-life of the agent, whichever is longer, prior to start of trial medication, History or evidence of clinically significant cardiovascular disease defined as at least one of the following criteria: Evidence of poorly controlled arterial hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); Myocardial infarction or unstable angina pectoris within 6 months before screening; Heart failure (New York Heart Association Class III or IV); Any cardiac arrhythmia that is not well controlled; QT corrected (QTc) prolongation = Grade 2 (> 480 ms) at screening measured on 2 separate electrocardiograms (ECG) at least 10 minutes apart; Clinically significant valvular heart disease, Pulmonary disease with clinically relevant hypoxia (need for continuous oxygen inhalation), Known Human Immunodeficiency Virus (HIV)-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome (AIDS)-related outcomes are eligible, if: No history of AIDS-defining opportunistic infection within past 12 months; Patient agrees to concomitant antiretroviral therapy (ART) if not currently on ART, is on ART for ? 4 weeks and has a HIV viral load ? 400 copies/mL, Active hepatitis., Any vaccines within 28 days before first study drug administration, History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease = 2 years before screening and of relatively low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of residual disease; Adequately treated carcinoma in situ without evidence of disease; Cancer patients with incidental histologic findings of prostate cancer that, in the opinion of the investigator, is not deemed to require
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