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)

Molecular Partners AG0 个研究点目标入组 75 人开始时间: 2023年2月2日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•1. Has signed and dated written informed consent prior to performing any study procedure, including screening
•2. Diagnosis of AML or MDS/AML according to the ELN recommendation 2022 (Appendix 12.1 of the protocol), refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell transplantation (HCT)
•3. Age =18 years old on the day of signing informed consent
•4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 (see Appendix 12.2 of the protocol)
•5. Anticipated life expectancy = 12 weeks by investigator judgement
•6. 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
•7. Is using highly effective contraception, for females of childbearing potential (FCBP) and for men
•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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Allogeneic HCT within the last 3 months
•2. Active GvHD requiring immune-suppressive therapy (other than prednisone (or equivalent) = 10mg/d)
•3. Use of immunosuppressive drugs (other than prednisone (or equivalent) =10mg/d) in the past 4 weeks
•4. Symptoms of leukostasis (prior hydroxyurea allowed)
•5. Clinical signs of AML in the central nervous system
•6. Major surgery within 28 days prior to start of study medication
•7. Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
•8. Any active infection requiring the use of parenteral antimicrobial agents or that is grade >2
•9. Treatment with agents targeting CD33, CD123 or CD70 within 4 weeks prior to start of trial medication
•10. Left ventricular ejection fraction of < 50% on echocardiographic exam at screening
•11. History or evidence of clinically significant cardiovascular disease
•12. Pulmonary disease with clinically relevant hypoxia
•13. Known Human Immunodeficiency Virus (HIV)-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome (AIDS)-related outcomes may be eligible (see protocol)
•14. Active hepatitis B (chronic or acute; HBV)
•15. Active hepatitis C (HCV) infection
•16. Any vaccines within 28 days before first study drug administration
•17. History of another primary malignancy may be excluded (see protocol)

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