Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Molecular Partners

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute; Relapsed; Myeloid; Leukemia

Treatments: Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05673057

MP0533-CP101

2022-002432-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has signed and dated written informed consent prior to performing any study procedure, including screening
• Diagnosis of AML or MDS/AML according to the ELN, refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell transplantation (HCT)
• 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
• Adequate renal and hepatic function:
• Is using highly effective contraception, for females of childbearing potential and for men

Exclusion criteria

• Allogeneic HCT within the last 3 months
• Active GvHD requiring immune-suppressive therapy
• Use of immunosuppressive drugs
• Symptoms of leukostasis (prior hydroxyurea allowed)
• 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 active infection requiring the use of parenteral antimicrobial agents or that is grade >2
• Treatment with investigational agents and/or agents targeting CD33, CD123 or CD70 within 4 weeks 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Dose escalation

Experimental group

Treatment:

Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)

Dose expansion

Experimental group

Treatment:

Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)