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

May 27, 2026 updated by: Cogent Biosciences, Inc.

Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Available
        • Orso Health/Modena Asthma Allergy
      • La Jolla, California, United States, 92037
        • Available
        • Scripps Green Hospital
      • Los Angeles, California, United States, 90095
        • Available
        • UCLA Ronald Reagan Medical Center
    • Illinois
      • Normal, Illinois, United States, 61761
        • Available
        • Sneeze Wheeze & Itch Associates LLC Clinical Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Available
        • Indiana University Health
    • Maine
      • Bangor, Maine, United States, 04401
        • Available
        • Northern Light Eastern Maine Medical Center
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Available
        • Walter Reed
      • Glenn Dale, Maryland, United States, 20769
        • Available
        • AllerVie Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02111
        • Available
        • Boston Specialists
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Available
        • Michigan Medicine- University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Available
        • Washington University School of Medicine in St. Louis
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Available
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Available
        • Duke Blood Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Available
        • The Ohio State University Wexner Medical Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Available
        • AIR Care
      • Houston, Texas, United States, 77030
        • Available
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • Available
        • The University of Texas, MD Anderson Cancer Center
    • Utah
      • Sandy City, Utah, United States, 84093
        • Available
        • Allergy Associates of Utah
    • Washington
      • Tacoma, Washington, United States, 98405
        • Available
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Key Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cogent Biosciences, Inc.

Investigators

  • Study Director: Rachael Easton, MD, PhD, Cogent Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGT9486-IEAP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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