Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome

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NCT05673057

Sponsored by Molecular Partners AG (industry) · MOLN — their whole pipeline →.

Phase

Phase 1/2

Status

Active, not recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

249estimated

Sites

Countries

France, Lithuania, Netherlands +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-12-29

actual

When the study began enrolling

Primary completion

2026-05-29

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

May 2027

estimated

The whole study's end, after follow-up

First posted

2023-01-06

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-09

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Leukemia
Myeloid
Acute
Newly Diagnosed

Interventions

Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1 — also filed as Part 1
Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A — also filed as Part 2 - Arm A
Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax — also filed as Part 2 - Arm B
Drug: MP0533 with Obinutuzumab pretreatment — also filed as Arm A
Drug: MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B relapsed/refractory AML — also filed as Arm B relapsed/refractory AML
Drug: MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B in treatment naïve patients — also filed as Arm B in treatment naïve patients

Primary outcomes

what the primary-completion date above is the date OF

Phase 1 dose escalation: Recommended Phase 2 Dose Regimen and/or Maximum Tolerated Dose Regimen

measured from start of treatment to end of first cycle (day 1 - 28)

Phase 2 dose extension: Overall Response Rate

measured throughout the study (on average 3 months)

Publications

PMID 38683145 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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