Phase 2 Study of PTX 100 for Patients with Relapsed or Hard-to-Treat Cutaneous T-Cell Lymphoma (CTCL)

Sponsor: Prescient Therapeutics, Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT06854653

Provider View

This clinical trial is testing a new drug, PTX-100, to see if it is safe and effective for patients with Cutaneous T-Cell Lymphoma (CTCL) that has returned or not responded to previous treatments. The study involves receiving the drug through an IV infusion over several cycles.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of PTX-100, a new treatment for patients with relapsed or refractory Cutaneous T-Cell Lymphoma (CTCL). Participants will receive PTX-100 through an IV infusion over a 60-minute period on days 1 to 5 of a 14-day cycle for the first four cycles, and then every 21 days thereafter. The study will last up to 18 months, during which participants will be monitored for treatment effects and any side effects.

Description

PTX-100 has shown promise in earlier studies for some patients with CTCL. This Phase II study will involve more participants to better understand its effects. Initially, 40 participants will be divided into two groups to receive different doses of PTX-100. After determining the best dose, 75 more participants will receive this dose in the next part of the study.

Participants will go through a 28-day screening period to confirm eligibility. Once eligible, they will start receiving PTX-100. Blood tests will be conducted on the first day of each treatment cycle to monitor safety and how the drug interacts with the body. Participants will also have skin evaluations and complete quality of life questionnaires at the start of each cycle. The study will continue until the disease progresses, side effects become unacceptable, or the participant or doctor decides to stop treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to provide informed consent.
  • Diagnosed with CTCL and confirmed by tests.
  • Must have Stage Ib or higher disease.
  • Previously tried at least two other treatments without success.
  • Have measurable disease by specific medical criteria.
  • Can be on a stable dose of certain corticosteroids.
  • Must wait a certain period after previous cancer treatments before starting the study.
  • Must test negative for HTLV1.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Life expectancy of at least 3 months.
  • Have adequate bone marrow, liver, and kidney function.
  • If HIV positive, must be on stable treatment with a low viral load.
  • Men must agree to use effective contraception during and after treatment.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Must be willing to follow study procedures.

Exclusion Criteria

  • Known involvement of the central nervous system.
  • Need for certain medications that affect drug processing in the body.
  • Significant heart or lung disease.
  • Active infections requiring treatment.
  • History of another cancer within the past 5 years, except for certain skin cancers.
  • Use of immunomodulatory drugs recently.
  • Active hepatitis infection, unless controlled.
  • Any condition that could interfere with the study.
  • Previous bone marrow transplant.
  • Psychiatric disorders affecting study compliance.
  • Recent history of drug or alcohol abuse.

Locations

FACILITYZIPCITYSTATE
City of Hope Comprehensive Cancer Cente91010DuarteCalifornia
University of California Irvine92697IrvineCalifornia
Yale Cancer Center06510New HavenConnecticut
Dana-Farber Cancer Institute022155450BostonMassachusetts
Rochester Skin Lymphoma Medical Group. PLLC14642RochesterNew York
Virginia Commonwealth University Massey Comprehensive Cancer Cente980037RichmondVirginia

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