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New drug aims to ease daily misery of rare mast cell disease

NCT ID NCT05186753

Symptom relief 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests whether the experimental drug bezuclastinib can reduce symptoms like itching, flushing, and fatigue in people with nonadvanced systemic mastocytosis, a rare condition where too many mast cells cause chronic discomfort. About 237 adults whose symptoms are not well controlled by current treatments will receive either bezuclastinib or a placebo daily for 28-day cycles. The study is double-blind and placebo-controlled, meaning neither patients nor doctors know who gets the real drug until the trial ends.

What this could mean

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

Active substance
bezuclastinib (CGT9486) tablets
What this could lead to
If successful, this could offer a new daily pill to better control symptoms like itching, flushing, and fatigue in people with nonadvanced systemic mastocytosis.
What could go wrong
This is a mid-stage trial with no results yet. The drug may not outperform placebo, and side effects are still being studied. It is not a cure.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 237 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Apr 2030

An estimate. End dates often move.

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

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Diagnosed with 1 of the following diagnoses according to the 2016 World Health Organization (WHO) classification for systemic mastocytosis (SM): * Indolent systemic mastocytosis (ISM), * Bone marrow mastocytosis (BMM) * Smoldering systemic mastocytosis (SSM) 2. Moderate-to-severe symptoms based on a minimum total symptom scoew (TSS) of the Mastocytosis Activity Score (MAS) and after establishing a stable regimen of at least 2 antimediator therapies over a 14-day eligibility period 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 4. For patients receiving corticosteroids, the dose must be ≤10 mg/day of prednisone or equivalent Key Exclusion Criteria: 1. Persistent toxicity from previous therapy for NonAdvSM that has not resolved to ≤ Grade 1 2. Diagnosed with any of the following WHO SM classifications: bone marrow mastocytosis, advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma 3. Diagnosed with mastocytosis of the skin without systemic involvement 4. Received prior treatment with any targeted KIT inhibitor with the exception of approved agents for the treatment of SM 5. Received prior cytoreductive therapy or investigational agent for \<14 days or 5 half- lives of the drug and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \<28 days or 5 half-lives of the drug (whichever is longer), before starting screening assessments 6. Received radiotherapy or psoralen and ultraviolet A therapy \<14 days before starting screening assessments 7. Received any hematopoietic growth factor support \<14 days or 5 half lives of the drug before starting screening assessments 8. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study 9. Need for treatment of corticosteroids at \>10 mg/day of prednisone or equivalent 10. Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives before the first dose of study drug

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Conditions

The condition(s) this trial relates to.

allergic disease hematologic disorder immune system disorder indolent systemic mastocytosis isolated bone marrow mastocytosis mastocytosis Mastocytosis, Systemic Smouldering systemic mastocytosis superficial spreading melanoma systemic mastocytosis type III hypersensitivity disease

As listed by the trial registrant

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

BMM Bone marrow mastocytosis ISM Mastocytosis Mastocytosis, indolent Mastocytosis, systemic Smoldering systemic mastocytosis SSM

Contacts and locations

Locations

  • AIR Care

    Dallas, Texas, 75231, United States

  • AOU Policlinico Rodolico San Marco

    Catania, Italy

  • AP-HP- Hopital Pitie-Salpetriere

    Paris, 75013, France

  • AUSL della Romagna-Ospedale S.Maria delle Croci

    Ravenna, Italy

  • Allervie Clinical Research

    Glenn Dale, Maryland, 20769, United States

  • Antwerp University Hospital (UZA)

    Edegem, 2650, Belgium

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Tivoli

    La Louvière, Belgium

  • CHU de Toulouse - Hopital Larrey

    Toulouse, 31400, France

  • Charité Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Cork University Hospital

    Cork, Ireland

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Duke University

    Raleigh, North Carolina, 27705, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus Rotterdam

    Rotterdam, Netherlands

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Czechia

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hospital Universitario Ramon y Cajal

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

    Bologna, 40138, Italy

  • Innovative Research of West Florida

    Clearwater, Florida, 33756, United States

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, Spain

  • Institute for Asthma and Allergy

    Wheaton, Maryland, 20902, United States

  • Instituto de Estudios de Mastocitosis de Castilla La Mancha-Hospital Virgen del Valle

    Toledo, Spain

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Metrodora Institute of Technology

    West Valley City, Utah, 84119, United States

  • Modena Allergy and Asthma Clinical

    La Jolla, California, 92037, United States

  • One of a Kind Clinical Research Center

    Scottsdale, Arizona, 85258, United States

  • Oslo University Hospital

    Oslo, 0424, Norway

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Rush University

    Chicago, Illinois, 60612, United States

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 - Klinika Hematoonkologii i Transplantacji Szpiku

    Lublin, Poland

  • St. James's Hospital

    Dublin, D08 NHY1, Ireland

  • St. Michael's Hospital

    Toronto, Ontario, Canada

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Universitaetsklinikum Aachen, AoeR

    Aachen, 52074, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • University Hospital Basel

    Basel, 4031, Switzerland

  • University Medical Center Groningen

    Groningen, 9713, Netherlands

  • University Medical Centre Mannheim

    Mannheim, 68167, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2R3, Canada

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Germany

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdansk, Poland

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37235, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814, United States

  • Washington University at St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.