NCT05673057 Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome
| NCT ID | NCT05673057 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Molecular Partners AG |
| Condition | Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 249 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2027-12 |
Trial Parameters
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Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Eligibility Criteria
Inclusion Criteria: * 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 * White blood count (WBC) ≤ 15G/L at day of trial drug infusion * Adequate renal and hepatic function * Is using highly effective contraception, for females of childbearing potential and for men Exclusion Criteria: * Mixed phenotype acute leukemia * Patients with favorable AML mutations according to ELN recommendation 2022 and 2024 * Allogeneic HCT within the last 3 months 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 (pa
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