RecruitingPhase 1Phase 2NCT05673057

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)


Sponsor

Molecular Partners AG

Enrollment

249 participants

Start Date

Dec 29, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests MP0533, a new multi-targeted drug designed to attack multiple proteins on leukemia cells at once, in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has relapsed or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory AML or MDS (as defined by current medical guidelines) - Your overall health is adequate (ECOG score 0–2) with an expected survival of at least 12 weeks - Your white blood cell count, kidney, and liver function meet the required thresholds - You are using effective contraception (if applicable) **You may NOT be eligible if...** - Your white blood cell count is above 15G/L at the time of treatment - You have severe organ dysfunction - You are pregnant or breastfeeding - You have received certain recent treatments that would exclude participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1

MP0533 is administered by intravenous infusion

DRUGMP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A

* MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered

DRUGMP0533 (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

DRUGMP0533 with Obinutuzumab pretreatment

* MP0533 is administered by intravenous infusion at densified dosing schedule * Obinutuzumab pretreatment administered

DRUGMP0533 + 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

DRUGMP0533 + 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


Locations(9)

CHU Bordeaux

Bordeaux, France

AP-HP Hôpital Saint-Louis

Paris, France

IUCT Oncopole

Toulouse, France

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Groningen UMC

Groningen, Provincie Groningen, Netherlands

Amsterdam UMC - Locatie VUmc

Amsterdam, Netherlands

Erasmus MC

Rotterdam, Netherlands

Inselspital, Universitaetsspital Bern

Bern, Canton of Bern, Switzerland

Universitaetsspital Zuerich

Zurich, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05673057


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