Actively Recruiting
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Led by K36 Therapeutics, Inc. · Updated on 2026-02-10
125
Participants Needed
22
Research Sites
279 weeks
Total Duration
On this page
Sponsors
K
K36 Therapeutics, Inc.
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).
CONDITIONS
Official Title
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- ECOG performance status of 0 or 1
- Diagnosed with multiple myeloma according to IMWG criteria
- Have received at least 3 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
- Refractory to the most recent prior therapy
- For cohorts A1/A2: exhausted available therapeutic options providing meaningful clinical benefit
- Confirmed t(4;14) genetic abnormality by standard FISH testing
- Measurable disease by at least one criteria: serum M protein ≥ 0.50 g/dL, serum IgA ≥ 0.50 g/dL for IgA myeloma, urine M protein ≥ 200 mg/24 h, involved serum free light chain ≥ 10 mg/dL, or bone marrow plasma cells ≥ 30% if only measurability criterion
- Agreement to enroll in the REMS program (for cohort D receiving pomalidomide)
You will not qualify if you...
- Prior mezigdomide treatment for patients in cohorts B1 and B2
- Carfilzomib use in the immediate last prior therapy for cohorts C1 and C2
- Pomalidomide use in the immediate last prior therapy for cohort D
- Radiation, chemotherapy, immunotherapy, or other anticancer therapy within 2 weeks prior to first dose
- Cellular therapies within 8 weeks prior to first dose
- Autologous transplant less than 100 days prior
- Allogenic transplant within 6 months prior or more than 6 months ago with active graft-versus-host disease
- Major surgery within 4 weeks prior
- Current plasma cell leukemia, POEMS syndrome, solitary bone lesion only, myelodysplastic syndrome, myeloproliferative neoplasm, or light chain amyloidosis
- Active central nervous system disease
- Inadequate bone marrow, kidney, liver, lung, or heart function
- Active uncontrolled infections
- Use of acid reducing agents or strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives prior
- Use of strong CYP1A2 inhibitors if receiving pomalidomide (cohort D)
- Active malignancy unrelated to myeloma requiring therapy within 2 years or not in complete remission, with exceptions defined in protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 22 locations
1
UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic
San Francisco, California, United States, 94143
Actively Recruiting
2
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Mayo Clinic - Transplant Center - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Atrium Health, Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
10
Duke University Hospital
Durham, North Carolina, United States, 27705
Actively Recruiting
11
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
14
University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
15
Universitaire de Lille
Villeneuve-d'Ascq, France, France
Actively Recruiting
16
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, France
Actively Recruiting
17
Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)
Poitiers, France
Actively Recruiting
18
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Actively Recruiting
19
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
20
Hospital ClÃ-nic de Barcelona
Barcelona, Spain
Actively Recruiting
21
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
22
Instituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, Spain
Actively Recruiting
Research Team
S
Soo Bang, MHSA
CONTACT
M
Miriam Barnett, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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