NCT05673057

Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 1/2a, First-in-human, Open-label, Multicenter, Dose Escalation Study of MP0533 in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 249 (estimated)
• Sponsor: Molecular Partners AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Leukemia
• Myeloid
• Acute
• Newly Diagnosed

Interventions

Type	Name	Description
DRUG	MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1	MP0533 is administered by intravenous infusion
DRUG	MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A	* MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered
DRUG	MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax	* MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered
DRUG	MP0533 with Obinutuzumab pretreatment	* MP0533 is administered by intravenous infusion at densified dosing schedule * Obinutuzumab pretreatment administered
DRUG	MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B relapsed/refractory AML	* MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered
DRUG	MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B in treatment naïve patients	* MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered

Timeline

• Start date: 2022-12-29
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2023-01-06
• Last updated: 2025-09-30

Locations

9 sites across 4 countries: France, Lithuania, Netherlands, Switzerland