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Study of BMF-219, in Adult Patients With Acute Leukemia, Diffuse Large B-Cell Lymphoma and Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT05153330
Recruitment Status : Recruiting
First Posted : December 10, 2021
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Biomea Fusion Inc.

Brief Summary:
A Phase1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral irreversible menin inhibitor, in adult patients with acute leukemia, diffuse large B-cell lymphoma, and multiple myeloma

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Mixed-Phenotype Leukemia Cancer Refractory Progression Diffuse Large B Cell Lymphoma Multiple Myeloma Lymphoma Lymphoma, Non-Hodgkin Myeloma, Plasma-Cell Myelomatosis Plasma Cell Myeloma Drug: BMF-219 Phase 1

Detailed Description:
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF 219, an oral irreversible menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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) and Cohort 3 (multiple myeloma) 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)
Primary Purpose: Treatment
Official Title: COVALENT-101: A Phase1 First-in-human Dose-escalation and Dose-expansion Study of BMF-219, an Oral Irreversible Menin Inhibitor, in Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), and Multiple Myeloma (MM)
Actual Study Start Date : January 24, 2022
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : June 21, 2023


Arm Intervention/treatment
Experimental: Dose Escalation Phase

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

Participants will receive 100 mg BMF-219 orally once per day to identify the OBD/RP2D (Optimal Biologic Dose/Recommended Ph2 Dose)

Dose Expansion Phase:

Cohorts 1, 2, and 3 will receive BMF-219 at the OPD/RP2D to further assess the safety/efficacy of the investigational drug.

Drug: BMF-219
BMF-219 is orally administered once daily in continuous 28 day cycles.
Other Name: Irreversible Menin Inhibitor

Experimental: Dose Expansion

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 25 mg BMF-219 orally once per day 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.

Drug: BMF-219
BMF-219 is orally administered once daily in continuous 28 day cycles.
Other Name: Irreversible Menin Inhibitor




Primary Outcome Measures :
  1. Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2 and 3) [ Time Frame: 28 days ]
    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), and multiple myeloma (Cohort 3)


Secondary Outcome Measures :
  1. Evaluate the Safety by treatment-emergent TEAEs and SAEs [ Time Frame: 32 cycles ]
    Evaluate the Safety by treatment-emergent TEAEs and SAEs Evaluate safety of BMF-219 as expressed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • All subjects must have histologically or pathologically confirmed diagnosis of their malignancy and/or measurable R/R disease, as follows:

    1. Cohort 1 only: Refractory or relapsed acute leukemia defined as > 5% blasts in the bone marrow or reappearance of blasts in the peripheral blood
    2. 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.
    3. Cohort 3 only: Measurable MM based on IMWG (International Myeloma Working Group) guidelines

Patients must be refractory or must have progressed on, or following discontinuation of the most recent anti-cancer therapy, with the following considerations:

  1. Cohort 1 only: Have failed or are ineligible for any approved standard of care therapies, including HSCT (Hematopoietic Stem Cell Transplantation)
  2. Cohort 2 only: Must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL (i.e., transformed from a previously diagnosed indolent lymphoma [e.g., follicular lymphoma])
  3. Cohort 3 only: Must have received at least 3 but no more than 6 prior anti-MM regimens including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory drug (IMiD) (e.g., lenalidomide or pomalidomide) therapy.

Exclusion Criteria:

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:

    1. Cohort 1: acute promyelocytic leukemia (APL), chronic myeloid leukemia (CML) in blast crisis, isolated extramedullary relapse (iEMR).
    2. Cohort 2: Primary mediastinal B-cell lymphoma (PMBCL), DLBCL transformed from diseases other than indolent non-Hodgkin's Lymphoma (NHL)
    3. Cohort 3: Active plasma cell leukemia, myeloma with amyloidosis, systemic light chain amyloidosis
  • White Blood Count (WBC) > 50,000/μL (uncontrollable with cytoreductive therapy)
  • Known central nervous involvement, as follows:

    1. Cohort 1: Clinically active central nervous system (CNS) leukemia. Previously controlled CNS leukemia is acceptable
    2. Cohort 2: Active CNS lymphoma or meningeal involvement
  • 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 (e.g., cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias not related to acute leukemia, DLBCL, or MM)
  • An active uncontrolled acute or chronic systemic fungal, bacterial, or viral infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05153330


Contacts
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Contact: Bhagyashree Yadav, MD 1-844-245-0490 clinicaltrials@biomeafusion.com
Contact: Clarissa Mandap 1-844-245-0490 clinicaltrials@biomeafusion.com

Locations
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United States, California
UCLA Department of Medicine Recruiting
Los Angeles, California, United States, 90095
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomea Fusion Inc.
Investigators
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Study Director: Alex Cacovean, MD Biomea Fusion Inc.
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Responsible Party: Biomea Fusion Inc.
ClinicalTrials.gov Identifier: NCT05153330    
Other Study ID Numbers: BF-MNN-101
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, Lymphoid