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A Study of TL-895 in Myelofibrosis, Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, or Non-Monoclonal Mast Cell Activation Syndrome
EU CTIS ID: 2024-514467-26-00
What this study is testing
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 TL-895 dosing regimen(s). 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. Part C: Cohort 5: To compare changes in ISM symptoms after treatment with TL-895 vs placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cohorts 1-6: Adults ≥18 years of age
- Cohort 4 only: Ineligibility for JAKi treatment with a platelet count of ≥ 15 and < 25x10^9/L
- Cohort 6: Moderate-to-severe chronic MCAS symptoms
- Cohort 6: Subject must have failed to achieve symptom control for one or more baseline chronic symptoms
- Cohort 6: The subject’s symptomatic MCAS therapies must be stable
- Cohorts 1-4: Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
You likely can't join if
- Cohorts 1-4: Prior treatment with JAKi within 28 days prior to first study treatment
- Cohorts 1-4: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
- Cohort 5: Diagnosis with another myeloid disorder
- Cohort 6: A current diagnosis of cutaneous or systemic mastocytosis as defined by WHO criteria
See the full eligibility criteria
- Cohorts 1-6: Adults ≥18 years of age
- Cohort 4 only: Ineligibility for JAKi treatment with a platelet count of ≥ 15 and < 25x10^9/L
- Cohort 6: Moderate-to-severe chronic MCAS symptoms
- Cohort 6: Subject must have failed to achieve symptom control for one or more baseline chronic symptoms
- Cohort 6: The subject’s symptomatic MCAS therapies must be stable
- Cohorts 1-4: 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 1-4: High-risk, intermediate-2 risk, or intermediate-1 risk, defined by DIPSS
- Cohorts 1-6: Adequate hematologic, hepatic, and renal functions
- Cohorts 1-4: 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 as defined by Working Group diagnostic criteria
- Cohorts 1-4: Prior treatment with JAKi within 28 days prior to first study treatment
- Cohorts 1-4: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
- Cohort 5: Diagnosis with another myeloid disorder
- Cohort 6: A current diagnosis of cutaneous or systemic mastocytosis as defined by WHO criteria
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- Korea, Republic of
- Taiwan
- Switzerland
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; Korea, Republic of; Taiwan; Switzerland; Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.