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MP0533 · 1 trial · 4 indications
Incidence of dose limiting toxicities, assessment of toxicity/safety, pharmacokinetic and efficacy parameters
Best overall response of complete remission (CR), complete remission with partial hematological recovery (CRh), complete remission with incomplete hematological recovery (CRi), morphologic leukemia-free state (MLFS) and partial remission (PR) according to the European LeukemiaNet (ELN) response criteria 2022
| Arm | Type | Description |
|---|---|---|
| Dose escalation (Part 1) | EXPERIMENTAL | • MP0533 is administered by intravenous infusion |
| Dose escalation (Part 2 - Arm A) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered |
| Dose escalation (Part 2 - Arm B) | EXPERIMENTAL | * 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) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion at densified dosing schedule * Obinutuzumab pretreatment administered |
| Dose expansion (Arm B relapsed/refractory AML) | EXPERIMENTAL | * 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) | EXPERIMENTAL | * 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 |
| Name | Type | Description |
|---|---|---|
| MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1 | DRUG | MP0533 is administered by intravenous infusion |
| MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A | DRUG | * MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered |
| MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax | DRUG | * 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 | DRUG | * 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 | DRUG | * 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 | DRUG | * 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 |
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...
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MP0533 is an investigational multispecific DARPin therapy developed by Molecular Partners AG for leukemia. It is designed as a CD3 engager that simultaneously targets CD33, CD123 and CD70. MP0533 has been studied as monotherapy in a Phase 1 clinical trial in patients with acute myeloid leukemia or myelodysplastic syndrome.
MP0533 is being developed for the treatment of leukemia, specifically acute myeloid leukemia and myelodysplastic syndrome. It was evaluated as monotherapy in a Phase 1 study in adults with newly diagnosed AML or MDS. The trial has been completed.
MP0533 targets CD33, CD123 and CD70 on leukemia cells, and CD3 on T cells. This multispecific DARPin design engages T cells to attack cells expressing these markers. The simultaneous targeting of three tumor-associated antigens aims to address tumor heterogeneity in acute myeloid leukemia.
MP0533 is being developed by Molecular Partners AG, a biopharmaceutical company listed under the ticker MOLN. The company is advancing MP0533 as a multispecific DARPin CD3 engager for leukemia.
MP0533 is in Phase 1 clinical development. A Phase 1 trial in acute myeloid leukemia and myelodysplastic syndrome has been completed. MP0533 is investigational and has not been approved by the FDA.
MP0533 has been studied in a Phase 1 clinical trial, NCT05673057, titled Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome. The trial enrolled 80 adults across France, Lithuania, the Netherlands, and Switzerland and is now completed.
Yes, MP0533 monotherapy, Part 1 refers to the monotherapy portion of the Phase 1 trial of MP0533, also described as the multispecific DARPin CD3 engager targeting CD33, CD123 and CD70. These names refer to the same investigational drug candidate.