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Acute Myeloid LeukemiaPhase 1NCT05153330

Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL

A Phase 1 study testing BMF-219 in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Biomea Fusion Inc. at 41 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMF-219
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
41 sitesin 5 countries
Study dates
24 Jan 2022to 2 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • All subjects must have histologically or pathologically confirmed diagnosis of their malignancy and/ or measurable R/ R disease, as follows:
  • Cohort 1 only: Refractory or relapsed acute leukemia defined as > 5% blasts in the bone marrow or reappearance of blasts in the peripheral blood.
  • Cohort 2 only: Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously indolent lymphoma (e.g., follicular lymphoma) with documented clinical or radiological evidence of progressive or persistent disease. At study entry, subjects must have measurable disease as per the revised criteria for response assessment of lymphoma.
  • Cohort 3 only: Measurable MM.
  • Cohort 4 only: Previously treated subjects with active CLL/SLL with meeting at least 1 of the iwCLL 2018 criteria for requiring treatment.
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  • Subjects must be refractory or must have progressed on, or following discontinuation of the most recent anti-cancer therapy, with the following considerations:
  • Cohort 1 only: Have failed or are ineligible for any approved standard of care therapies, including HSCT (Hematopoietic Stem Cell Transplantation).
  • Cohort 2 only: Must have received at least 2 previous systemic regimens for the treatment of their de novo or transformed DLBCL.
  • Cohort 3 only: Must have received at least 3 anti-MM regimens including proteasome inhibitor.
  • Cohort 4 only: Must have received at least 2 prior systemic treatment regimens.
  • ECOG performance status of 0-2 and an estimated expected life expectancy of > 3 months in the opinion of the Investigator.
  • Adequate organ function.
  • Both men and women of childbearing potential or their partners must use adequate birth control measures during the course of the trial and for at least 90 days after discontinuing study treatment.

Who cannot join

  • Subjects who meet any of the following criteria will not be enrolled in the study (all cohorts, unless otherwise indicated):
  • Certain disease subtypes or occurrences, as follows:
  • Cohort 1: Acute promyelocytic leukemia (APL), chronic myeloid leukemia (CML) in blast crisis.
  • Cohort 2: Primary mediastinal B-cell lymphoma (PMBCL), DLBCL transformed from diseases other than indolent non-Hodgkin's Lymphoma (NHL).
  • Cohort 3: Active plasma cell leukemia, myeloma with amyloidosis, systemic light chain amyloidosis.
  • Cohort 4: Known or suspected history of Richter's transformation.
Show all 16Show fewer
  • White Blood Count (WBC) > 50,000/μL (uncontrollable with cytoreductive therapy) (Cohort 1 only).
  • Known central nervous involvement, as follows:
  • Cohort 1: Clinically active central nervous system (CNS) leukemia. Previously controlled CNS leukemia is acceptable.
  • Cohort 2: Active CNS lymphoma or meningeal involvement.
  • Cohort 3: Active CNS MM.
  • Cohort 4: Active CNS leukemia.
  • Prior menin inhibitor therapy.
  • Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
  • Subjects with a pre-existing disorder predisposing them to a serious or life-threatening infection.
  • An active uncontrolled acute or chronic systemic fungal, bacterial, or viral infection.

Trial locations and contacts

41 sites in 5 countries.

41 sites in 5 countries

United States17 sites

  • Blood & Marrow Transplant Group of GA (Northside Hospital)

    Atlanta, Georgia, 30342

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Virginia Cancer Specialists

    Gainesville, Virginia, 20155

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California, Irvine

    Irvine, California, 92697

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Southern California Norris Cancer Center

    Los Angeles, California, 90033

  • UCLA Department of Medicine

    Los Angeles, California, 90095

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Stanford Cancer Center

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Spain11 sites

  • Hospital General de Albacete

    Albacete, 02006

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia

    Barcelona, 08916

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

Other trials in Spain

Italy7 sites

  • AOU Ospedali Riuniti Ancona

    Ancona, 60126

  • ASST Papa Giovanni XXIII Hospital Bergamo

    Bergamo, 24128

  • Instituto Clinico Humanitas

    Milan, 20089

  • IRCCS Ospedale San Raffaele, Programma di Ricerca Strategica su LLC

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 435 - 20141

  • Ospedale Santa Maria della Misericordia

    Perugia, 06132

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

Other trials in Italy

Netherlands4 sites

  • Amsterdam UMC

    Amsterdam, 1081HV

  • UMCG Groningen

    Groningen, 9700 RB

  • Radboud University Medical Center

    Nijmegen, 6500 HB

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015 GD

Other trials in Netherlands

Greece2 sites

  • Evangelismos General Hospital of Athens

    Athens, 106 76

  • Alexandra General Hospital of Athens

    Athens, 115 28

Other trials in Greece

About this study

Official title: A Phase 1 First-in-human Dose-escalation and Dose-expansion Study of BMF-219, an Oral Covalent Menin Inhibitor, in Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), and Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.

Read the detailed description

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) with mixed lineage leukemia 1-rearranged (KMT2A/ MLL1r), nucleophosmin 1 (NPM1), diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic lymphoma (CLL)/ small lymphocytic lymphoma (SLL).

Being tested
BMF-219
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms, Disease Progression, Lymphoma, Large B-Cell, Diffuse, Multiple Myeloma, Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMF-219Drug

    Also called Covalent Menin Inhibitor

    BMF-219 is orally administered in continuous 28 day cycles. Alternative BID dosage may be used.

Study groups in NCT05153330
Study groupRoleWhat they receive
Dose Escalation PhaseExperimentalExperimental: 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.
Receives: Drug: BMF-219
Dose ExpansionExperimentalExperimental: 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.
Receives: Drug: BMF-219

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4)

    Determine Optimal Biologic Dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy in subjects with refractory or relapsed (R/ R) acute leukemia (Cohort 1), diffuse large B-cell lymphoma (Cohort 2), multiple myeloma (Cohort 3), and chronic lymphocytic leukemia/ small lymphocytic lymphoma (Cohort 4).

    Measured: At the end of Cycle 1 (each Cycle is 28 Days in duration)

Secondary outcomes (1)

  1. Evaluate the Safety treatment-emergent TEAEs and SAEs

    Evaluate the Safety of BMF-219 as expressed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

    Measured: 28 Days after last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start24 Jan 2022
  3. Primary completion13 Feb 2025
  4. Study completion2 May 2025

Why it stopped: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The first-in-human (FIH) study is a dose-escalation/dose-expansion study of BMF-219. During the dose-escalation phase of the study, the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 will be determined. Subjects in Cohort 1 (acute leukemia) are assigned to one of two parallel arms; ARM A (subjects not receiving CYP3A4 inhibitors) and ARM B (subjects receiving CYP3A4 inhibitors); Subjects in Cohort 2 (DLBCL), Cohort 3 (multiple myeloma), and Cohort 4 (chronic lymphocytic leukemia/ small lymphocytic lymphoma) are assigned to a single arm (ARM A).The dose-expansion phase will obtain further safety, as well as efficacy data for BMF-219 when dosed at the OBD and RP2D.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153330
Sponsor's protocol ID
COVALENT-101
Status last verified
Jul 2025
First submitted
30 Nov 2021
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMF-219 in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Biomea Fusion Inc. at 41 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Spain, Italy, Netherlands, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4) (time frame: At the end of Cycle 1 (each Cycle is 28 Days in duration)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05153330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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