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90 Participants NeededMy employer runs this trial

Bexmarilimab + Azacitidine for Preleukemia

(BEXERA Trial)

Recruiting at 34 trial locations
JW
PB
Overseen ByPetri Bono, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Faron Pharmaceuticals Ltd
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with treatment-naïve higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomized to receive bexmarilimab at one of two dose levels (1 mg/kg or 3 mg/kg) plus azacitidine, or placebo plus azacitidine. The primary aim is to select the recommended dose of bexmarilimab for subsequent development based on a predefined integration of clinical response and safety/tolerability.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed, higher-risk myelodysplastic syndromes (a type of preleukemia) who haven't had prior treatment. Participants need to have good organ function, a certain level of bone marrow blasts and white blood cells, be able to take azacitidine, and have a life expectancy of at least 3 months.

Inclusion Criteria

My bone marrow biopsy shows less than 20% blasts.
My condition is classified as moderately high, high, or very high risk by IPSS-M.
I have signed a consent form to join the study.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • Bexmarilimab

Trial Overview

The study compares two treatments: one group gets the new drug bexmarilimab (at either low or high dose) plus azacitidine; the other group gets placebo plus azacitidine. The goal is to see which dose works best and how safe it is in people with higher-risk MDS.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Bexmarilimab (3mg/kg) and azacitidineExperimental Treatment2 Interventions
Group II: Bexmarilimab (1mg/kg) and azacitidineExperimental Treatment2 Interventions
Group III: Placebo and azacitidinePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Faron Pharmaceuticals Ltd

Lead Sponsor

Trials
9
Recruited
780+

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