RecruitingPhase 2NCT06854653

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

An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.


Sponsor

Prescient Therapeutics, Ltd.

Enrollment

115 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called PTX-100 for people with cutaneous T-cell lymphoma (CTCL) — a type of blood cancer that mainly affects the skin — whose disease has come back or stopped responding to previous treatments. **You may be eligible if:** - You are 18 years or older - You have a confirmed diagnosis of CTCL at Stage Ib or higher - You have tried and failed or could not tolerate at least 2 prior treatments - You are in reasonably good health (ECOG score 0–2) - You have adequate organ function (blood, liver, kidneys) - You do not have HIV, or if you do, it is well controlled on antiviral therapy **You may NOT be eligible if:** - The lymphoma has spread to your brain or spinal cord - You are taking strong medications that interact with the study drug - You have significant heart disease or severely impaired lung function - You have an active serious infection - You have had another cancer in the past 5 years (with limited exceptions) - You have had a bone marrow or stem cell transplant - You have known active viral hepatitis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPTX-100

Peptidomimetic inhibitor of GGTase 1


Locations(15)

City of Hope Comprehensive Cancer Cente

Duarte, California, United States

University of California Irvine

Irvine, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Rochester Skin Lymphoma Medical Group. PLLC

Rochester, New York, United States

Virginia Commonwealth University Massey Comprehensive Cancer Cente

Richmond, Virginia, United States

Westmead Hospital

Westmead, New South Wales, Australia

Epworth Healthcare

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

CHU de Bordeaux - Hopital Saint André

Bordeaux, Bordeaux, France

Hopital Lyon Sud

Lyon, Pierre-Benite, France

Hopital Saint Louis

Paris, Île-de-France Region, France

IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, Bologna, Italy

Universita degli Studi Di Brescia-Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, Brescia, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

Milan, Milano, Italy

View Full Details on ClinicalTrials.gov

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NCT06854653


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