Status:
AVAILABLE
Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Lead Sponsor:
Cogent Biosciences, Inc.
Conditions:
Systemic Mastocytoses, Indolent
Systemic Mastocytoses, Aggressive
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06915766
Last Update
November 5 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Orso Health/Modena Asthma Allergy
La Jolla, California, United States, 92037
2
Indiana University Health
Indianapolis, Indiana, United States, 46202
3
Walter Reed
Bethesda, Maryland, United States, 20889
4
AllerVie Health
Glenn Dale, Maryland, United States, 20769