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NCT06854653 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
A Phase 2 study of CTCL, sponsored by Prescient Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 15
- Study locations
NCT06854653: Recruiting Phase 2 study of CTCL, sponsored by Prescient Therapeutics.
NCT06854653 is a Phase 2 study of CTCL that is actively recruiting participants, run by Prescient Therapeutics. The registered enrollment target is 115 participants, above the 48-participant average among 4 other CTCL trials with a reported enrollment target (140% higher). The trial reports 15 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06854653, a Phase 2 study of CTCL, is actively recruiting participants, sponsored by Prescient Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
Objective response rate (ORR): ORR is defined as the proportion of patients who achieved CR or PR as their best response
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 |
What NCT06854653 shows while recruiting
NCT06854653 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 48-participant average among 4 other CTCL trials with a reported enrollment target (140% higher).
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.
NCT06854653 lists 15 locations in 14 states (California, Connecticut, Massachusetts).
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.
What interventions are being tested in trial NCT06854653?
The interventions under investigation include: PTX-100 (DRUG).
Who is sponsoring clinical trial NCT06854653?
This trial is sponsored by Prescient Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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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