Overview

(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Status:
Recruiting
Trial end date:
2026-11-01
Target enrollment:
Participant gender:
Summary
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of CGT9486 plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1 and 2 will receive CGT9486 or placebo, and may roll over onto Part 3 to receive treatment with CGT9486.
Phase:
Phase 2
Details
Lead Sponsor:
Cogent Biosciences, Inc.