OncoMatch/Clinical Trials/NCT05673057
Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome
Is NCT05673057 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for leukemia.
Treatment: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1 · MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A · MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax · MP0533 with Obinutuzumab pretreatment · MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B relapsed/refractory AML · MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B in treatment naïve patients — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Excluded: CD33 targeted therapy
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
Excluded: CD123 targeted therapy
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
Excluded: CD70 targeted therapy
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
Allowed: FLT3 mutation
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
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic cell transplant
Exception: allowed if >3 months prior
Allogeneic HCT within the last 3 months
Cannot have received: targeted therapy (e.g. gilteritinib for FLT3 mutated AML) (gilteritinib)
Exception: unless already given and proven ineffective, contraindicated, confounding mutations, or lack of access
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
Cannot have received: investigational agent
Exception: allowed if >4 weeks or >5x half-life prior to start of trial medication
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
Cannot have received: venetoclax (venetoclax)
received VEN in prior treatment lines (Arm B only)
Lab requirements
Kidney function
Adequate renal function
Liver function
Adequate hepatic function
Cardiac function
Left ventricular ejection fraction of < 50% on echocardiographic exam at screening [excluded]; history or evidence of clinically significant cardiovascular disease [excluded]
Adequate renal and hepatic function. Left ventricular ejection fraction of < 50% on echocardiographic exam at screening [excluded]; history or evidence of clinically significant cardiovascular disease [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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