Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL
NCT05153330 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2025-07-03
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.
Conditions
- 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
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Interventions
- DRUG
-
BMF-219
BMF-219 is orally administered in continuous 28 day cycles. Alternative BID dosage may be used.
Sponsors & Collaborators
-
Biomea Fusion Inc.
lead INDUSTRY
Principal Investigators
-
Steve Morris, MD · Biomea Fusion Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-24
- Primary Completion
- 2025-02-13
- Completion
- 2025-05-02
- FDA Drug
- Yes
Countries
- United States
- Greece
- Italy
- Netherlands
- Spain
Study Locations
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