Clinical trial · Interventional
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent Systemic Mastocytosis | Indolent Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| TL-895 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (13)
- type
- EXPERIMENTAL
- label
- Cohort 1a, Relapsed/Refractory Myelofibrosis
- description
- 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
- interventionNames
- Drug: TL-895
- type
- EXPERIMENTAL
- label
- Cohort 1b, Relapsed/Refractory Myelofibrosis
- description
- 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
- interventionNames
- Drug: TL-895
- type
- EXPERIMENTAL
- label
- Cohort 1c, Relapsed/Refractory Myelofibrosis
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Cohorts 1-3 Key Inclusion Criteria: * Adults ≥18 years of age * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 * Adequate hematologic, hepatic, and renal functions * 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 Key Exclusion Criteria: * Prior treatment with any BTK or BMX inhibitors * Prior treatment with JAKi within 28 days prior to study treatment * Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment Cohort 5 Key Inclusion Criteria: * Adults ≥18 years of age * Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results * Subject must have moderate-to-severe symptoms Key Exclusion Criteria: * Prior treatment with any BTK or BMX inhibitors * Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib * Diagnosis with another myeloproliferative disorder
References
Publications (0)
Data not yet available