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Phase 2 Study of PTX-100 for Relapsed/Refractory CTCL

This study is testing a drug called PTX-100 for people with Cutaneous T-Cell Lymphoma (CTCL) that has come back or hasn't responded to previous treatments. PTX-100 works by blocking a protein called GGTase 1. We want to see how well PTX-100 works to shrink tumors or stop their growth. To join, you must be at least 18 years old and have a confirmed diagnosis of CTCL that is Stage Ib or higher. The study will measure how many patients respond to PTX-100 over 18 months. The current status of this study is unclear, but it plans to enroll 115 participants.

Study design
This is an open-label, phase 2 study that will enroll 115 participants. Initially, 40 participants will be randomly assigned to receive one of two different doses of PTX-100, and then 75 more participants will receive the best dose.
What's involved
You will have a 28-day screening period to see if you qualify. If eligible, you will receive PTX-100 through an IV infusion for 5 days every two weeks for 4 cycles, then every three weeks. You will have blood tests, skin evaluations, and safety exams on the first day of each cycle, and will complete quality of life questionnaires.
Compensation
Not stated in the trial record.
Follow-up
You will be treated or followed for up to 18 months, or until your disease gets worse, you experience unacceptable side effects, or you or your doctor decide to stop.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06854653

A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

Recruiting
PHASE2Ages 18+InterventionalTreatment
Prescient Therapeutics, Ltd.
~115 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:PTX-100

At a glance

Recruiting sites
12 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the efficacy of PTX-100 as determined by ORR.
Measured over 18 months from day of first treatment until disease progression, unacceptable toxicity, participant or Investigator decision.

Conditions

CTCL

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Where it's being run

15 sites across 14 states
California2
Connecticut1
Massachusetts1
New York1
Virginia1
New South Wales1
Victoria1
Western Australia1

Who to contact

Upaly Bahadure
[email protected]
+61 3 9692 7222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Not a woman of childbearing potential (WOCBP).
OR
A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle, beginning the time of informed consent, during the treatment period and for at least 3 months after the last dose of study treatment. 19. A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment. 20. Must be willing and able to adhere to the study as judged by the Investigator.

What this trial measures

  • To determine the efficacy of PTX-100 as determined by ORR.18 months from day of first treatment until disease progression, unacceptable toxicity, participant or Investigator decision.

    Objective response rate (ORR): ORR is defined as the proportion of patients who achieved CR or PR as their best response