Gene Therapy Clinical Trials

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: BMF-219

Eligibility


Inclusion Criteria:

   - Age ≥ 18 years.

   - All subjects must have histologically or pathologically confirmed diagnosis of their
   malignancy and/ or measurable R/ R disease, as follows:

      1. Cohort 1 only: Refractory or relapsed acute leukemia defined as > 5% blasts in
      the bone marrow or reappearance of blasts in the peripheral blood.

      2. 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.

      3. Cohort 3 only: Measurable MM.

      4. Cohort 4 only: Previously treated subjects with active CLL/SLL with meeting at
      least 1 of the iwCLL 2018 criteria for requiring treatment.

   - Subjects 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 previous systemic regimens for the
      treatment of their de novo or transformed DLBCL.

      3. Cohort 3 only: Must have received at least 3 anti-MM regimens including
      proteasome inhibitor.

      4. Cohort 4 only: Must have received at least 2 prior systemic treatment regimens.

   - ECOG performance status of 0-2 and an estimated expected life expectancy of > 3 months
   in the opinion of the Investigator.

   - Adequate organ function.

   - Both men and women of childbearing potential or their partners must use adequate birth
   control measures during the course of the trial and for at least 90 days after
   discontinuing study treatment.

Exclusion Criteria:

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:

      1. Cohort 1: Acute promyelocytic leukemia (APL), chronic myeloid leukemia (CML) in
      blast crisis.

      2. Cohort 2: Primary mediastinal B-cell lymphoma (PMBCL), DLBCL transformed from
      diseases other than indolent non-Hodgkin's Lymphoma (NHL).

      3. Cohort 3: Active plasma cell leukemia, myeloma with amyloidosis, systemic light
      chain amyloidosis.

      4. Cohort 4: Known or suspected history of Richter's transformation.

   - White Blood Count (WBC) > 50,000/μL (uncontrollable with cytoreductive therapy)
   (Cohort 1 only).

   - Known central nervous involvement, as follows:

      1. Cohort 1: Clinically active central nervous system (CNS) leukemia. Previously
      controlled CNS leukemia is acceptable.

      2. Cohort 2: Active CNS lymphoma or meningeal involvement.

      3. Cohort 3: Active CNS MM.

      4. Cohort 4: Active CNS leukemia.

   - 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.

   - An active uncontrolled acute or chronic systemic fungal, bacterial, or viral
   infection.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mani Gupta
650-723-0501
Not Recruiting