Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

Available (expanded access)

Conditions studied: Systemic Mastocytoses, Indolent, Systemic Mastocytoses, Aggressive

In brief

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.

Key facts

Study ID

NCT06915766

Run by

Cogent Biosciences, Inc.

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Orso Health/Modena Asthma Allergy — La Jolla, California, United States
• Scripps Green Hospital — La Jolla, California, United States
• UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
• Sneeze Wheeze & Itch Associates LLC Clinical Research Center — Normal, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Northern Light Eastern Maine Medical Center — Bangor, Maine, United States
• Walter Reed — Bethesda, Maryland, United States
• AllerVie Health — Glenn Dale, Maryland, United States
• Boston Specialists — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Michigan Medicine- University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke Blood Cancer Center — Durham, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• AIR Care — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Allergy Associates of Utah — Sandy City, Utah, United States
• Northwest Medical Specialties — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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