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Menin Inhibitor

BMF-219 for Blood Cancers

Phase 1
Recruiting
Research Sponsored by Biomea Fusion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable MM (Cohort 3)
Histologically or pathologically confirmed diagnosis of malignancy and/or measurable R/R disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of cycle 1 (each cycle is 28 days in duration)
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug, BMF-219, to see if it is safe and effective in treating adults with acute leukemia, diffuse large B-cell lymphoma, and multiple myeloma.

Who is the study for?
Adults with certain blood cancers like AML, ALL with specific mutations, DLBCL, MM, and CLL/SLL can join this trial. They must have relapsed or refractory cancer despite previous treatments, be over 18 years old with good organ function and willing to use birth control. People are excluded if they have active CNS involvement by their cancer or a history of certain other conditions.Check my eligibility
What is being tested?
The study is testing BMF-219, an oral drug designed to block menin's action in the body. It's for adults who've seen their blood cancer return or not respond to treatment. The trial will gradually increase doses to find the safest and most effective level.See study design
What are the potential side effects?
As a first-in-human study for BMF-219, detailed side effects aren't listed but may include typical reactions related to immune system changes such as fatigue, nausea, fever; organ-specific inflammation; allergic reactions; and potential impact on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your multiple myeloma can be measured.
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You have been diagnosed with cancer and have measurable recurrent or refractory disease.
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You have acute leukemia that has not responded to treatment or has come back with a high percentage of leukemia cells in your bone marrow or blood.
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You have a specific type of lymphoma called DLBCL that has not improved with previous treatment.
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You have a type of leukemia called CLL/SLL and meet specific criteria for needing treatment.
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You have not responded to or have stopped responding to your most recent cancer treatment.
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You are able to perform daily activities without help and are expected to live for more than 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of cycle 1 (each cycle is 28 days in duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 1 (each cycle is 28 days in duration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4)
Secondary outcome measures
Therapeutic procedure

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Experimental: ARM B: Study participants who are receiving a moderate or strong CYP3A4 inhibitor. Dose Escalation Phase: • Cohort 1: Participants with acute leukemia will receive escalating dose BMF-219 orally to identify the OBD/ RP2D (Optimal Biologic Dose/Recommended Ph2 Dose). Dose Expansion Phase: Cohort 1 will receive BMF-219 at the OBD/ RP2D to further assess the safety and efficacy of the investigational drug.
Group II: Dose Escalation PhaseExperimental Treatment1 Intervention
Experimental: ARM A: Study participants who are not receiving a moderate or strong CYP3A4 inhibitor. Dose Escalation Phase: Cohort 1: Participants with acute leukemia Cohort 2: Participants with diffuse large B-cell lymphoma Cohort 3: Participants with multiple myeloma Cohort 4: Participants with chronic lymphocytic leukemia/ small lymphocytic lymphoma Participants will receive escalating dose BMF-219 orally once per day to identify the OBD/RP2D (Optimal Biologic Dose/Recommended Ph2 Dose). Dose Expansion Phase: Cohorts 1, 2, 3, and 4 will receive BMF-219 at the OBD/ RP2D to further assess the safety/ efficacy of the investigational drug.

Find a Location

Who is running the clinical trial?

Biomea FusionLead Sponsor
Biomea Fusion Inc.Lead Sponsor
4 Previous Clinical Trials
538 Total Patients Enrolled
Alex Cacovean, MDStudy DirectorBiomea Fusion Inc.

Media Library

BMF-219 (Menin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05153330 — Phase 1
Lymphoma Research Study Groups: Dose Escalation Phase, Dose Expansion
Lymphoma Clinical Trial 2023: BMF-219 Highlights & Side Effects. Trial Name: NCT05153330 — Phase 1
BMF-219 (Menin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153330 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How detrimental could BMF-219 be to human health?

"BMF-219 was assigned a safety score of 1 due to the limited data available at this early stage in its development. Phase 1 trials only provide preliminary evidence for both effectiveness and safeguard."

Answered by AI

How many participants are being recruited for this research endeavor?

"Affirmative. The information on clinicaltrials.gov reveals that the study is presently recruiting participants and has been since January 24th 2022. Last edited on October 24th 2022, this medical trial seeks to enrol 120 individuals between 12 locations."

Answered by AI

How widespread is the implementation of this research in Canada?

"The current clinical trial has a total of 12 sites, including UC Davis Comprehensive Cancer Center (Sacramento), Blood & Marrow Transplant Group of GA (Northside Hospital) in Atlanta and Mount Sinai Medical Centre in Miami Beach. Additionally, there are 9 other participating locations."

Answered by AI

Are there any available slots left to participate in this experiment?

"The data on clinicaltrials.gov depicts an ongoing recruitment for this trial, which was initially made available to the public on January 24th 2022 and recently updated in October of that same year."

Answered by AI
~59 spots leftby Feb 2025