BMF-219 for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lymphoma+19 More
BMF-219 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, BMF-219, to see if it is safe and effective in treating adults with acute leukemia, diffuse large B-cell lymphoma, and multiple myeloma.

Eligible Conditions
  • Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma
  • Multiple Myeloma
  • Leukemia, Myelocytic, Acute
  • Refractory
  • Progression
  • Acute Lymphoblastic Leukemia (ALL)
  • Lymphoma, Diffuse
  • Malignancies
  • Acute Mixed-Phenotype Leukemia
  • Diffuse Large B-Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: At the end of Cycle 1 (each Cycle is 28 Days in duration)

28 days
Determine Optimal Biologic Dose (OBD)
Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2 and 3)
32 cycles
Evaluate the Safety by treatment-emergent TEAEs and SAEs
Day 28
Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4)
Therapeutic procedure

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Dose Escalation Phase
1 of 2
Dose Expansion
1 of 2
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: BMF-219 · No Placebo Group · Phase 1

Dose Escalation Phase
Drug
Experimental Group · 1 Intervention: BMF-219 · Intervention Types: Drug
Dose Expansion
Drug
Experimental Group · 1 Intervention: BMF-219 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of cycle 1 (each cycle is 28 days in duration)

Who is running the clinical trial?

Biomea FusionLead Sponsor
Biomea Fusion Inc.Lead Sponsor
Alex Cacovean, MDStudy DirectorBiomea Fusion Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Cohort 1 only: Patients with acute leukemia who have had a complete remission and are free of disease for at least 6 months.
You have an estimated life expectancy of 3 months or less

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.