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Bexmarilimab + Standard Care for Acute Myeloid Leukemia (BEXMAB Trial)

Phase 1 & 2
Recruiting
Led By Mika Kontro, MD, PhD
Research Sponsored by Faron Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CMML and MDS patient with response failure to HMA or therapy regimen including HMA.
Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
Must not have
Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count > 13 x10^9/L.
History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety & efficacy of a drug, bexmarilimab, when combined with standard care for MDS, CMML or AML; Phase 1 to identify recommended dose, Phase 2 to assess preliminary efficacy.

Who is the study for?
Adults with certain blood cancers like MDS, CMML-2, or AML who have specific risk levels or treatment histories can join. They need good kidney and liver function and a low enough white blood cell count. People with acute promyelocytic leukemia, poor physical status, recent transplants, active autoimmune diseases (with some exceptions), current heavy immunosuppression use, or recent other cancer treatments cannot participate.
What is being tested?
The trial is testing Bexmarilimab combined with standard treatments Azacitidine and Venetoclax in patients with specific types of blood cancers. It's in two phases: the first to find the safest dose level of Bexmarilimab and the second to see how well it works at that dose for these conditions.
What are the potential side effects?
While not specified here, drugs like Bexmarilimab may cause immune-related effects since they target the body’s immune system. Standard care drugs can lead to side effects such as nausea, fatigue, bleeding problems and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My CMML or MDS did not improve with HMA treatment.
Select...
I have AML and cannot undergo standard treatment, but can take azacitidine-venetoclax.
Select...
My AML has returned or didn't respond after 1 treatment, and I need azacitidine.
Select...
I have been diagnosed with CMML-2 and need azacitidine treatment.
Select...
My MDS is classified as intermediate, high, or very high risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have APL or CMML with a high white blood cell count.
Select...
I have a severe liver condition or chronic ulcers.
Select...
I had a transplant from another person less than 6 months ago.
Select...
It's been less than 21 days since my last IV cancer treatment or less than 14 days since my last oral cancer medication.
Select...
I need steroids or other drugs to suppress my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AMLExperimental Treatment3 Interventions
Standard of care venetoclax and/or azacitidine as per label plus bexmarilmab
Group II: Phase 1 - Newly diagnosed AML patients non-fit for induction therapyExperimental Treatment3 Interventions
Standard of care azacitidine and venetoclax as per label; bexmarilimab 4 dose levels Q1W followed by Q2W; 28-day cycle
Group III: Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AMLExperimental Treatment2 Interventions
Standard of care azacitidine as per label; bexmarilimab 4 dose levels at once every week (Q1W) followed by once every 2 weeks (Q2W); 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2240
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Faron Pharmaceuticals LtdLead Sponsor
8 Previous Clinical Trials
601 Total Patients Enrolled
Mika Kontro, MD, PhDPrincipal InvestigatorHelsinki University Central Hospital

Media Library

Azacitidine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05428969 — Phase 1 & 2
Myelodysplastic Syndrome Research Study Groups: Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AML, Phase 1 - Newly diagnosed AML patients non-fit for induction therapy, Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AML
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT05428969 — Phase 1 & 2
Azacitidine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05428969 — Phase 1 & 2
~22 spots leftby Apr 2025
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