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Trial Title:
Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT ID:
NCT05673057
Condition:
Leukemia
Relapsed
Myeloid
Acute
Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Conditions: Keywords:
DARPin
CD33
CD123
CD70
T-cell/CD3 engager
multispecific
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)
Description:
Phase 1 comprises the dose-escalation part of the study and is designed to determine the
recommended phase 2a dose regimen (RP2D-R) and/or the maximum tolerated dose-regimen
(MTD-R) for MP0533 monotherapy.
Once the RP2D-R or MTD-R has been selected based on the dose escalation part, the study
will proceed into the phase 2 expansion part and up to 30 additional patients will be
treated.
Arm group label:
Dose escalation
Arm group label:
Dose expansion
Other name:
DARPin
Summary:
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)
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Bordeaux
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Facility:
Name:
AP-HP Hôpital Saint-Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
IUCT Oncopole
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Facility:
Name:
Vilnius University Hospital Santaros Klinikos
Address:
City:
Vilnius
Country:
Lithuania
Status:
Recruiting
Facility:
Name:
Amsterdam UMC - Locatie VUmc
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Groningen UMC
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Inselspital, Universitaetsspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Universitaetsspital Zuerich
Address:
City:
Zuerich
Zip:
8006
Country:
Switzerland
Status:
Recruiting
Start date:
December 29, 2022
Completion date:
December 2027
Lead sponsor:
Agency:
Molecular Partners AG
Agency class:
Industry
Source:
Molecular Partners AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673057
