A study of MP0533 in patients with blood cancer.
- Conditions
- relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2022-002432-31-LT
- Lead Sponsor
- Molecular Partners AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method