Trials / Terminated
TerminatedNCT05153330
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 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)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Biomea Fusion Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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).
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
| Type | Name | Description |
|---|---|---|
| DRUG | BMF-219 | BMF-219 is orally administered in continuous 28 day cycles. Alternative BID dosage may be used. |
Timeline
- Start date
- 2022-01-24
- Primary completion
- 2025-02-13
- Completion
- 2025-05-02
- First posted
- 2021-12-10
- Last updated
- 2025-07-03
Locations
41 sites across 5 countries: United States, Greece, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05153330. Inclusion in this directory is not an endorsement.