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

M

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)

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)

Trial contacts and locations

9

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Central trial contact

Medical DirectorG MPAG

Data sourced from clinicaltrials.gov

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