A Study of TL-895 in Myelofibrosis, Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, or Non-Monoclonal Mast Cell Activation Syndrome

Phase 2

Active, not recruiting

• Conditions: Indolent Systemic Mastocytosis; Mast Cell Activation Syndrome; Myelofibrosis

• Registration Number: 2024-514467-26-00
• Lead Sponsor: Telios Pharma Inc.

Brief Summary

Part A: Cohorts 1-4: To determine the recommended phase 2 dose and schedule of TL-895 in each cohort.

Part A: Cohort 5: To determine the recommended phase 3 dose of TL-895.

Part A: Cohort 6: To determine the recommended phase 3 dose of TL-895.

Part B: Cohorts 1-4: Improvement in Total Symptom Score at Week 24

Part B: Cohort 5: To assess changes in ISM symptoms after treatment with TL-895.

Part B Cohort 6: To assess changes in MCAS symptoms after treatment with TL-895.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-11
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Cohorts 1-3: Adults ≥18 years of age

Cohorts 1-3: Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria

Cohorts 1-3: Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Cohorts 1-3: Adequate hematologic, hepatic, and renal functions

Cohorts 1-3: MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0

Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10^9/L

Cohort 5: Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results

Cohort 5: Subject must have moderate-to-severe symptoms

Cohort 6: Confirmed diagnosis of MCAS

Exclusion Criteria

Cohorts 1-3, 5: Prior treatment with any BTK or BMX inhibitors

Cohorts 1-3: Prior treatment with JAKi within 28 days prior to study treatment

Cohorts 1-3: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Cohort 5: Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib

Cohort 5: Diagnosis with another myeloproliferative disorder

Cohort 6: Treatment with certain prior therapies as defined in protocol

Cohort 6: A current diagnosis of cutaneous or systemic mastocytosis as defined by WHO criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the recommended phase 2 dose		To determine the recommended phase 2 dose
To determine the recommended phase 3 dose		To determine the recommended phase 3 dose
Improvement in total symptom score at Week 24		Improvement in total symptom score at Week 24
Assess changes in ISM symptoms		Assess changes in ISM symptoms
Assess changes in MCAS symptoms		Assess changes in MCAS symptoms

Trial Locations

Locations (30)

Centre Hospitalier Le Mans; 🇫🇷 Le Mans Cedex 9, France

Centre Hospitalier Universitaire De Nice; 🇫🇷 Nice, France

Military Medical Academy; 🇧🇬 Sofiya, Bulgaria

Centre hospitalier universitaire de Liege; 🇧🇪 Liege, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Sint-Lambrechts-Woluwe, Belgium

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania; 🇮🇹 Catania, Italy

Azienda Unita Sanitaria Locale Della Romagna; 🇮🇹 Ravenna, Italy

Grande Ospedale Metropolitano Bianchi Melacrino Morelli; 🇮🇹 Reggio Calabria, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, Italy

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Centre Hospitalier Le Mans

🇫🇷Le Mans Cedex 9, France

Kamel Laribi

Site contact

0243434361

klaribi@ch-lemans.fr