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A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
NCT06854653 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.
Conditions Studied
Interventions
- DRUG PTX-100
Study Locations (15)
California
- City of Hope Comprehensive Cancer Cente — Duarte
- University of California Irvine — Irvine
Connecticut
- Yale Cancer Center — New Haven
Massachusetts
- Dana-Farber Cancer Institute — Boston
New York
- Rochester Skin Lymphoma Medical Group. PLLC — Rochester
Virginia
- Virginia Commonwealth University Massey Comprehensive Cancer Cente — Richmond
New South Wales
- Westmead Hospital — Westmead
Victoria
- Epworth Healthcare — Melbourne
Western Australia
- Linear Clinical Research — Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2025-03-28 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06854653
The ClinicalTrials.gov registry entry for NCT06854653 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prescient Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with CTCL appearing as the primary indexed condition, and to 1 intervention — of which PTX-100 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: NCT06854653 reports 15 study locations spanning 14 distinct geographic areas — top geographies include California, Connecticut, Massachusetts. 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 NCT06854653 about?
NCT06854653 is a clinical study titled "A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL". This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). PTX-100 will be administered by IV infusion over 60 min...
What is the current status of trial NCT06854653?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2025-03-28. Estimated completion is 2028-06.
What conditions does trial NCT06854653 study?
This clinical trial studies the following conditions: CTCL. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06854653?
The interventions under investigation include: PTX-100 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06854653?
This trial is sponsored by Prescient Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06854653 being conducted?
This trial has 15 study locations across California, Connecticut, Massachusetts, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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