Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
1 other identifier
expanded_access
N/A
1 country
18
Brief Summary
The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.
Trial Health
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18 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedMarch 9, 2026
March 1, 2026
March 31, 2025
March 6, 2026
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent and commit to EAP assessments.
- ≥18 years of age.
- Able to swallow tablets.
- Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM
- Not receiving adequate disease control on current therapy(ies).
- Have clinically acceptable laboratory screening results.
You may not qualify if:
- Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.
- Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.
- Pregnant or currently breastfeeding.
- Prior or ongoing clinically significant illness or medical or physical condition
- Other protocol-defined criteria apply.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Orso Health/Modena Asthma Allergy
La Jolla, California, 92037, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
Sneeze Wheeze & Itch Associates LLC Clinical Research Center
Normal, Illinois, 61761, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Walter Reed
Bethesda, Maryland, 20889, United States
AllerVie Health
Glenn Dale, Maryland, 20769, United States
Boston Specialists
Boston, Massachusetts, 02111, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Michigan Medicine- University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke Blood Cancer Center
Durham, North Carolina, 27705, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
AIR Care
Dallas, Texas, 75231, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rachael Easton, MD, PhD
Cogent Biosciences, Inc.
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 8, 2025
Last Updated
March 9, 2026
Record last verified: 2026-03