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Study of TL-895 for Patients with Relapsed or Refractory Myelofibrosis or Indolent Systemic Mastocytosis

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called TL-895 in individuals with certain blood-related conditions. The diseases being studied are Myelofibrosis and Indolent Systemic Mastocytosis. Myelofibrosis is a disorder where scar tissue forms in the bone marrow, affecting blood cell production. Indolent Systemic Mastocytosis is a condition where there is an abnormal accumulation of mast cells, a type of white blood cell, in various tissues. The medication TL-895 is taken orally in the form of a film-coated tablet.

The purpose of this study is to determine the appropriate dose and schedule for TL-895 in treating these conditions. Participants in the study will receive either the medication or a placebo. The study will be conducted over a period of time, during which participants will be monitored for changes in their symptoms and overall health. The study aims to find out if TL-895 can improve symptoms and reduce the size of the spleen in patients with Myelofibrosis, as well as assess changes in symptoms for those with Indolent Systemic Mastocytosis.

Throughout the study, participants will be regularly assessed to ensure their safety and to evaluate the effectiveness of the treatment. The study will help determine if TL-895 is a viable treatment option for these conditions and will provide valuable information on how best to use the medication in future treatments. The trial is expected to conclude by the end of 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed based on specific criteria related to age, diagnosis, and health status.

    Eligibility is determined by a confirmed diagnosis of either myelofibrosis or indolent systemic mastocytosis.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate symptoms and overall health.

    This includes a review of medical history and current symptoms.

  3. Step 3

    Medication administration

    The medication TL-895 is administered in the form of a film-coated tablet.

    The route of administration is oral, meaning the tablet is taken by mouth.

  4. Step 4

    Dose determination

    The study aims to determine the recommended phase 2 dose and schedule of TL-895.

    This involves monitoring the effects of the medication over time.

  5. Step 5

    Symptom monitoring

    Symptoms are monitored regularly to assess any changes or improvements.

    This includes tracking the Total Symptom Score at specific intervals, such as at week 24.

  6. Step 6

    End of study

    The study is estimated to conclude by December 31, 2025.

    Final assessments are conducted to evaluate the overall impact of the treatment.

Who can join the trial?

8 criteria

  • For Cohorts 1-3: You must be an adult aged 18 years or older.
  • For Cohorts 1-3: You need a confirmed diagnosis of one of the following: Primary Myelofibrosis (PMF), post-Polycythemia Vera Myelofibrosis (post-PV MF), or post-Essential Thrombocythemia Myelofibrosis (post-ET MF). This diagnosis should be made by your doctor following the World Health Organization (WHO) criteria.
  • For Cohorts 1-3: You should have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that helps doctors understand how your disease affects your daily living abilities.
  • For Cohorts 1-3: You must have adequate blood, liver, and kidney functions.
  • For Cohorts 1-3: You should have symptoms of Myelofibrosis (MF) with at least 2 symptoms scoring an average of at least 1 on a specific symptom assessment form (MFSAF v4.0) during the week before starting the study.
  • For Cohort 3 only: You must be ineligible for JAK inhibitor treatment and have a platelet count between 25 and 50 x 109/L. Platelets are cells in your blood that help with clotting.
  • For Cohort 5: You need a confirmed diagnosis of Indolent Systemic Mastocytosis (ISM) based on a review of your bone marrow biopsy pathology report results, following WHO diagnostic criteria.
  • For Cohort 5: You must have moderate-to-severe symptoms.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of allergic reactions to similar medications.
  • Patients who are unable to follow the study procedures.
  • Patients with certain types of infections that are not well controlled.
  • Patients with a history of substance abuse that might affect the study.
  • Patients who have had a recent major surgery.
  • Patients with certain heart conditions that are not stable.
  • Patients with severe liver or kidney problems.
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Investigated drugs

TL-895 is an investigational medication being studied for its potential use in treating certain types of myelofibrosis and indolent systemic mastocytosis. Myelofibrosis is a rare type of bone marrow cancer that disrupts the body's normal production of blood cells. This medication is being tested in patients who have not responded well to other treatments or who cannot tolerate other medications. The study aims to find the best dose and schedule for using TL-895 to help improve symptoms in these patients.

What is already known about the treatment

TL-895 – TL-895 is an investigational medication currently being studied in clinical trials for its potential use in treating myelofibrosis and indolent systemic mastocytosis. It is administered orally, allowing for convenient use. The medication is in the phase 2 stage of clinical trials, where researchers are determining the optimal dose and schedule for patients. TL-895 works by inhibiting specific enzymes involved in the signaling pathways that contribute to the growth and survival of abnormal cells. It is classified as a kinase inhibitor, targeting pathways that are often overactive in certain blood disorders.

Investigated diseases

  • Myelofibrosis

    Myelofibrosis is a rare bone marrow disorder where the marrow is replaced by fibrous tissue, leading to a decrease in blood cell production. This condition often results in anemia, fatigue, and an enlarged spleen. Over time, the body's ability to produce blood cells diminishes, causing various symptoms related to low blood counts. Patients may experience weakness, weight loss, and night sweats. The disease can progress slowly, but the symptoms can significantly impact daily life.

  • Indolent Systemic Mastocytosis

    Indolent Systemic Mastocytosis is a condition characterized by an abnormal accumulation of mast cells in various tissues, including the skin, bone marrow, and internal organs. This accumulation can lead to symptoms such as skin rashes, itching, and abdominal discomfort. The disease is termed "indolent" because it progresses slowly and often has a stable course. Patients may experience episodes of flushing, low blood pressure, and gastrointestinal issues. Despite the chronic nature of the condition, it typically does not lead to organ damage.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514467-26-00Protocol codeTL-895-201Estimated enrolment308 patientsSponsorTelios Pharma Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).