Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

NCT05280509 · View on ClinicalTrials.gov ↗

Study Summary

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

Interventions

  • DRUG Ruxolitinib
  • DRUG TL-895

Study Locations (19)

Other

  • CHU Angers — Angers
  • AP-HM - Hôpital de la Timone — Marseille
  • CHU de Nice - Hopital L'Archet II — Nice
  • Hôpital Saint Louis - AP-HP — Paris
  • Centre Hospitalier Lyon Sud — Pierre-Bénite
  • Marien Hospital Duesseldorf — Düsseldorf
  • Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall — Halle
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola — Bologna
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano — Milan
  • Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia — Perugia
  • Pratia Onkologia Katowice — Katowice
  • Hospital Universitari Arnau de Vilanova — Lleida
  • Hospital Universitario Ramon y Cajal — Madrid
  • Hospital Universitario Virgen de la Victoria — Málaga
  • Hospital Quironsalud de Zaragoza — Zaragoza

Ohio

  • Gabrail Cancer Center — Canton
  • University of Cincinnati (UC) — Cincinnati

Alabama

  • University of Alabama at Birmingham — Birmingham

Texas

  • The University of Texas MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2022-06-09
Est. Completion 2027-04
Phase Phase 1

Sponsor

Telios Pharma

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05280509

The ClinicalTrials.gov registry entry for NCT05280509 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Telios Pharma, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 2 interventions — of which Ruxolitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05280509 reports 19 study locations spanning 4 distinct geographic areas — top geographies include Other, Ohio, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05280509 about?

NCT05280509 is a clinical study titled "Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib". This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

What is the current status of trial NCT05280509?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2022-06-09. Estimated completion is 2027-04.

What conditions does trial NCT05280509 study?

This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05280509?

The interventions under investigation include: Ruxolitinib (DRUG), TL-895 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05280509?

This trial is sponsored by Telios Pharma, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05280509 being conducted?

This trial has 19 study locations across Alabama, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial