Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT ID: NCT05673057
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
249 participants
INTERVENTIONAL
2022-12-29
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation (Part 1)
• MP0533 is administered by intravenous infusion
MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1
MP0533 is administered by intravenous infusion
Dose escalation (Part 2 - Arm A)
* MP0533 is administered by intravenous infusion
* Obinutuzumab pretreatment administered
MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A
* MP0533 is administered by intravenous infusion
* Obinutuzumab pretreatment administered
Dose escalation (Part 2 - Arm B)
* 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
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
Dose expansion (Arm A)
* MP0533 is administered by intravenous infusion at densified dosing schedule
* Obinutuzumab pretreatment administered
MP0533 with Obinutuzumab pretreatment
* MP0533 is administered by intravenous infusion at densified dosing schedule
* Obinutuzumab pretreatment administered
Dose expansion (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
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
Dose expansion (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
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
Interventions
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MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1
MP0533 is administered by intravenous infusion
MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A
* MP0533 is administered by intravenous infusion
* Obinutuzumab pretreatment administered
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
MP0533 with Obinutuzumab pretreatment
* MP0533 is administered by intravenous infusion at densified dosing schedule
* Obinutuzumab pretreatment administered
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 (patient relapsed or resistant to), or contraindicated, or confounding mutations exist, or there is a lack of access to this recommended therapy.
* More than 2 prior lines of anti-leukemic therapy
* Active GvHD requiring immune-suppressive therapy
* Use of immunosuppressive drugs
* Clinical signs of AML in the central nervous system
* Major surgery within 28 days prior to start of study medication
* Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
* Any uncontrolled active infection
* Treatment with investigational agents or agents targeting CD33, CD123 or CD70 within 4 weeks or five times the half-life of the agent, whichever is longer, prior to start of trial medication
* Left ventricular ejection fraction of \< 50% on echocardiographic exam at screening
* History or evidence of clinically significant cardiovascular disease
* Pulmonary disease with clinically relevant hypoxia
* Active hepatitis
* Concurrent enrolment in another clinical trial, unless it is an observational (non-interventional) study or it is the follow-up period of an interventional study
* Known hypersensitivity to any of the excipients of the investigational medicinal product (IMP), i.e. finished MP0533 drug
Dose Expansion Group (Arm B in treatment-naïve patients only):
Inclusion
• Treatment-naïve patients who are eligible to AZA+VEN as standard of care
Dose Escalation and Expansion Groups (Arm B only):
Exclusion
1. received VEN in prior treatment lines
2. received strong and/or moderate CYP3A inducers within 7 days before the initiation of AZA/VEN regimen;
3. Has consumed grapefruit, grapefruit products, Seville oranges or Starfruit within 3 days before the initiation of AZA/VEN regimen;
4. Has a malabsorption syndrome or other condition that precludes the enteral route of administration of VEN.
18 Years
ALL
No
Sponsors
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Molecular Partners AG
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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References
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Bianchi M, Reichen C, Croset A, Fischer S, Eggenschwiler A, Grubler Y, Marpakwar R, Looser T, Spitzli P, Herzog C, Villemagne D, Schiegg D, Abduli L, Iss C, Neculcea A, Franchini M, Lekishvili T, Ragusa S, Zitt C, Kaufmann Y, Auge A, Hanggi M, Ali W, Frasconi TM, Wullschleger S, Schlegel I, Matzner M, Luthi U, Schlereth B, Dawson KM, Kirkin V, Ochsenbein AF, Grimm S, Reschke N, Riether C, Steiner D, Leupin N, Goubier A. The CD33xCD123xCD70 Multispecific CD3-Engaging DARPin MP0533 Induces Selective T Cell-Mediated Killing of AML Leukemic Stem Cells. Cancer Immunol Res. 2024 Jul 2;12(7):921-943. doi: 10.1158/2326-6066.CIR-23-0692.
Other Identifiers
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2023-505259-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
2022-002432-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MP0533-CP101
Identifier Type: -
Identifier Source: org_study_id
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