Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

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)

Details

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)

Keywords

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 Leukemia Neoplasms, Plasma Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse BMF-219

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 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.

You CAN'T join if...

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, isolated extramedullary relapse (iEMR).
  • 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
  • White Blood Count (WBC) > 50,000/μL (uncontrollable with cytoreductive therapy)
  • 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
  • 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

Locations

  • UCLA Department of Medicine accepting new patients
    Los Angeles California 90095 United States
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biomea Fusion Inc.
ID
NCT05153330
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated