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NCT05153330 · ClinicalTrials.gov registry record · Phase 1

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, sponsored by Biomea Fusion.

Terminated
Registry status
Phase 1
Development phase
55
Enrollment target

NCT05153330: Clinical Trial Phase 1 study, sponsored by Biomea Fusion.

NCT05153330 is a Phase 1 study that was terminated before completion, run by Biomea Fusion. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05153330, a Phase 1 study, was terminated before completion, sponsored by Biomea Fusion.

TERMINATED
Registry status
Phase 1
Development phase
55 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • DRUG BMF-219

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2022-01-24
Est. Completion 2025-05-02
Phase Phase 1
Biomea Fusion

9 total trials

Why NCT05153330 stopped before completion

NCT05153330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which BMF-219 is the first listed.

NCT05153330 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05153330 about?

NCT05153330 is a clinical study titled "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 AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.

What is the current status of trial NCT05153330?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2022-01-24. Estimated completion is 2025-05-02.

What interventions are being tested in trial NCT05153330?

The interventions under investigation include: BMF-219 (DRUG).

Who is sponsoring clinical trial NCT05153330?

This trial is sponsored by Biomea Fusion, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05153330's enrollment target sits among peer trials

55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05153330, the US trial registry maintained by the National Library of Medicine. NCT05153330 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.