Systemic Mastocytoses, IndolentNCT06915766
Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
A study testing Bezuclastinib in people with Systemic Mastocytoses, Indolent and Systemic Mastocytoses, Aggressive, run by Cogent Biosciences, Inc. at 23 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Mastocytoses, Indolent, Systemic Mastocytoses, Aggressive
- What is being tested?
- Bezuclastinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 23 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
- Available
Michigan Medicine- University of Michigan
Ann Arbor, Michigan, 48109
Jocelyn Rice, jocerice@med.umich.edu
- Available
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
Denise Michaud, dmichaud@northernlight.org
207-973-7175
- Available
Walter Reed
Bethesda, Maryland, 20889
Nathan Boggs, MD, PhD, nathan.boggs@usuhs.edu
- Available
Boston Specialists
Boston, Massachusetts, 02111
Lina Fikri, research@bfac.org
- Available
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Morgan Vitale, Morgan_vitale@dfci.harvard.edu
- Available
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Jennifer Vaughn, MD, jennifer.vaughn2@osumc.edu
- Available
AIR Care
Dallas, Texas, 75231
Lucinda Van Anglen, lvananglen@healix.net
- Available
Duke Blood Cancer Center
Durham, North Carolina, 27705
Sherry Huber, RN, BSN, sherry.huber@duke.edu
- Available
AllerVie Health
Glenn Dale, Maryland, 20769
Arnold Kirshenbaum, MD, akirshenbaum@allervie.com
- Available
Texas Children's Hospital
Houston, Texas, 77030
832-824-1319, Joud.Hajjar@bcm.edu
- Available
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Shareen Gopal, sgopal@mdanderson.org
- Available
Indiana University Health
Indianapolis, Indiana, 46202
Craig Sewell, DO, cdsewell@iu.edu
- Available
Orso Health/Modena Asthma Allergy
La Jolla, California, 92037
Allyson Cyr, 858-260-2977, acyr@orso-health.com
Brian Modena, MD
- Available
Scripps Green Hospital
La Jolla, California, 92037
Cristina Ortega, Ortega.Cristina@scrippshealth.org
- Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Frederick Lansigan, MD, 603-650-4628, frederick.lansigan@hitchcock.org
Frederick Lansigan, MD
- Available
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
Bruck Habtemariam, BHabtemariam@mednet.ucla.edu
310-794-0242
- Available
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Brian Chernak, MD, 646-608-4266, chernakb@mskcc.org
- Available
Sneeze Wheeze & Itch Associates LLC Clinical Research Center
Normal, Illinois, 61761
Stephanie Oliver, 309-451-7509
Abby Feit, 309-503-5576
- Available
Mayo Clinic
Rochester, Minnesota, 55905
Thanai Pongdee, MD, 507-284-5689, pongdee.thanai@mayo.edu
- Available
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Aleeza Nazeer, aleeza.nazeer@hci.utah.edu
- Available
Allergy Associates of Utah
Sandy City, Utah, 84093
Sandy Warr, 801-263-8700, sandy.warr@utahallergies.com
- Available
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Kyra Ddungu, 314-273-8790, dkyra@wustl.edu
- Available
Northwest Medical Specialties
Tacoma, Washington, 98405
Jeni Spokely, 253-999-3701, Research@southsoundcare.org
About this study
Official title: 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.
- Being tested
- Bezuclastinib
- Keywords
- Systemic Mastocytosis, NonAdvanced Systemic Mastocytosis, Advanced Systemic Mastocytosis, Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN), Aggressive Systemic Mastocytosis (ASM), Mast Cell Leukemia (MCL), Bone Marrow Mastocytosis (BMM)
- Medical subject headings
- Mastocytosis, Systemic, Leukemia, Mast-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezuclastinibDrug
Also called CGT9486
Drug: Bezuclastinib Tablets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Mastocytoses, IndolentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachael Easton, MD, PhD, Study director, Cogent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915766
- Sponsor's protocol ID
- CGT9486-IEAP-001
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
- ClinicalTrials.gov ID
- NCT06915766
- Acronym / sponsor ID
- CGT9486-IEAP-001
- Keywords
- Systemic Mastocytosis, NonAdvanced Systemic Mastocytosis, Advanced Systemic Mastocytosis, Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN), Aggressive Systemic Mastocytosis (ASM), Mast Cell Leukemia (MCL), Bone Marrow Mastocytosis (BMM)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BezuclastinibAlso: CGT9486Drug: Bezuclastinib Tablets | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael Easton, MD, PhD study director
Cogent Biosciences, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bezuclastinib in people with Systemic Mastocytoses, Indolent and Systemic Mastocytoses, Aggressive, run by Cogent Biosciences, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Malinowski, PharmD (1-877-633-8049, EAP@cogentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.