Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04996875 · ClinicalTrials.gov registry record · Phase 2
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
A Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN), sponsored by Cogent Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT04996875: Recruiting Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN), sponsored by Cogent Biosciences.
NCT04996875 is a Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN) that is actively recruiting participants, run by Cogent Biosciences. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04996875, a Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN), is actively recruiting participants, sponsored by Cogent Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Conditions Studied
Interventions
- DRUG bezuclastinib
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- UCLA Medical Center - Los Angeles
- Stanford Cancer Institute - Stanford
Other
- AKH Wien, Universitatsklinikum - Vienna
- CHU de Liege - Liège
Alabama
- University of Alabama at Birmingham (UAB) Hospital - Birmingham
Arizona
- Mayo Clinic Arizona - Phoenix
Florida
- Galiz Research - Hialeah
Georgia
- Winship Cancer Institute - Emory University - Atlanta
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What NCT04996875 shows while recruiting
NCT04996875 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 4 conditions, with Advanced Systemic Mastocytosis (AdvSM) appearing as the primary indexed condition, and to 1 intervention - of which bezuclastinib is the first listed.
NCT04996875 names 20 study sites across 17 states, led by California, Other, Alabama.
Frequently Asked Questions
What is clinical trial NCT04996875 about?
NCT04996875 is a clinical study titled "(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis". This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
What is the current status of trial NCT04996875?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2021-11-09. Estimated completion is 2026-07.
What conditions does trial NCT04996875 study?
This clinical trial studies the following conditions: Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM).
What interventions are being tested in trial NCT04996875?
The interventions under investigation include: bezuclastinib (DRUG).
Who is sponsoring clinical trial NCT04996875?
This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04996875 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04996875's enrollment target sits among peer trials
140 512th of 2000 higher than 1,477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01419561 · 140 participants · Phase 2
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
- NCT01624805 · 140 participants · Phase 2
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome
- NCT02369770 · 140 participants · NA
Sensory-Motor Rehabilitation Post Stroke
- NCT02455193 · 140 participants · NA
Neuronal Effects of Exercise in Schizophrenia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI