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New hope for mastocytosis patients: expanded access to bezuclastinib

NCT ID NCT06915766

Disease control Sponsor: Cogent Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This program provides the investigational drug bezuclastinib to adults with systemic mastocytosis who have failed or cannot tolerate standard treatments. Participants must be at least 18 years old and able to swallow tablets. The goal is to offer a potential treatment option when no satisfactory alternatives exist.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bezuclastinib (also known as CGT9486)
What this could lead to
If this drug works, it could offer a new treatment option for patients with systemic mastocytosis who have run out of standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so data on effectiveness and safety is still limited. The drug may not work for everyone and could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aggressive systemic mastocytosis indolent systemic mastocytosis isolated bone marrow mastocytosis mast cell leukemia Mastocytosis, Systemic Smouldering systemic mastocytosis systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic mastocytoses, aggressive Systemic mastocytoses, indolent

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    23 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIR Care

    AVAILABLE

    Dallas, Texas, 75231, United States

  • AllerVie Health

    AVAILABLE

    Glenn Dale, Maryland, 20769, United States

  • Allergy Associates of Utah

    AVAILABLE

    Sandy City, Utah, 84093, United States

  • Boston Specialists

    AVAILABLE

    Boston, Massachusetts, 02111, United States

    Contact Email: •••••@•••••

  • Dana Farber Cancer Institute

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Dartmouth-Hitchcock Medical Center

    AVAILABLE

    Lebanon, New Hampshire, 03756, United States

  • Duke Blood Cancer Center

    AVAILABLE

    Durham, North Carolina, 27705, United States

  • Indiana University Health

    AVAILABLE

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic

    AVAILABLE

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    AVAILABLE

    New York, New York, 10065, United States

  • Michigan Medicine- University of Michigan

    AVAILABLE

    Ann Arbor, Michigan, 48109, United States

  • Northern Light Eastern Maine Medical Center

    AVAILABLE

    Bangor, Maine, 04401, United States

  • Northwest Medical Specialties

    AVAILABLE

    Tacoma, Washington, 98405, United States

    Contact Email: •••••@•••••

  • Orso Health/Modena Asthma Allergy

    AVAILABLE

    La Jolla, California, 92037, United States

  • Scripps Green Hospital

    AVAILABLE

    La Jolla, California, 92037, United States

  • Sneeze Wheeze & Itch Associates LLC Clinical Research Center

    AVAILABLE

    Normal, Illinois, 61761, United States

  • Texas Children's Hospital

    AVAILABLE

    Houston, Texas, 77030, United States

  • The Ohio State University Wexner Medical Center

    AVAILABLE

    Columbus, Ohio, 43210, United States

  • The University of Texas, MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • UCLA Ronald Reagan Medical Center

    AVAILABLE

    Los Angeles, California, 90095, United States

  • University of Utah - Huntsman Cancer Institute

    AVAILABLE

    Salt Lake City, Utah, 84112, United States

  • Walter Reed

    AVAILABLE

    Bethesda, Maryland, 20889, United States

  • Washington University School of Medicine in St. Louis

    AVAILABLE

    St Louis, Missouri, 63110, United States

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