Access to Bezuclastinib for Patients with Systemic Mastocytosis

Sponsor: Cogent Biosciences, Inc.

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06915766

Provider View

This program provides access to the investigational drug bezuclastinib for patients with systemic mastocytosis who have not responded to or cannot tolerate standard treatments, and have no other suitable options.

Patient Parameters

Program Overview

This program is designed to offer the investigational drug bezuclastinib to patients diagnosed with either nonadvanced or advanced systemic mastocytosis. It is intended for those who have tried at least one approved treatment without success or cannot tolerate it, and who have no other comparable treatment options available.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written consent and participate in program assessments.
  • Must be 18 years or older.
  • Must be able to swallow tablets.
  • Must have a diagnosis of systemic mastocytosis, including ASM, SM-AHN, MCL, BMM, ISM, or SSM, according to the 2022 WHO Classification.
  • Must not have adequate disease control with current treatments.
  • Must have acceptable lab test results.

Exclusion Criteria

  • Cannot be eligible for or enrolled in an ongoing bezuclastinib clinical trial.
  • Cannot have stopped using bezuclastinib in past trials due to side effects or personal choice.
  • Cannot be pregnant or breastfeeding.
  • Cannot have any significant ongoing illness or medical condition.

Other specific criteria may apply.

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