A Phase 2 Study of TL-895 in Myelofibrosis or indolent systemic mastocytosis
Research type
Research Study
Full title
A Phase 2, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
IRAS ID
1009324
Contact name
Khushboo Vyas
Contact email
Sponsor organisation
Telios Pharma, Inc.
Eudract number
2020-002393-27
Clinicaltrials.gov Identifier
Research summary
Myelofibrosis (MF) and indolent systemic mastocytosis (ISM) are diseases affecting the stem cells that lead to a large increase of cells in the bone marrow, which can cause cancer cells to grow, spread, and form tumours.
TL-895-201 is a Phase 2 study to test how well MF and ISM responds to TL-895 treatment, determine how long any benefits last, and evaluate how the body reacts to varying doses. The study medication TL-895 is an orally available inhibitor of Bruton's tyrosine kinase (BTK), a gene that plays a role in B cell development.
Eligible participants must have a confirmed diagnosis of MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria if they are in cohorts 1-4. If the participant is in cohort 5, eligible participants must have confirmed diagnosis of ISM as defined by WHO diagnostic criteria. In the UK, participants will be enrolled into Cohort 5 (ISM) only.
The primary objective is to determine the recommended Phase 2 dose and schedule of TL-895 in each cohort. Telios Pharma, Inc. (the Sponsor) is responsible for the development of TL-895 and the oversight of this study. Approximately 70 patients are expected to take part in this study at medical centres in North America, Asia Pacific, and Europe, including the UK.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0046
Date of REC Opinion
8 Apr 2024
REC opinion
Further Information Favourable Opinion