What is PTX-100 studying for Cutaneous T-Cell Lymphoma?

PTX-100 is being studied to evaluate its effects on relapsed or refractory Cutaneous T-Cell Lymphoma. Researchers aim to learn how well it works, how safe it is, and how it behaves in the body. This research is sponsored by Prescient Therapeutics, Ltd.

Who may be eligible for this Cutaneous T-Cell Lymphoma clinical trial?

Adults 18 years or older with confirmed CTCL who have failed or cannot tolerate at least two prior systemic treatments may be eligible. Participants must have measurable disease and be able to provide informed consent. Please review eligibility criteria for more details.

Is there any cost to participate in this Cutaneous T-Cell Lymphoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06854653

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

Led by Prescient Therapeutics, Ltd. · Updated on 2026-04-29

115

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating PTX-100 monotherapy in adult patients with relapsed or refractory Cutaneous T-Cell Lymphoma CTCL to assess its efficacy, safety, pharmacokinetics PK, and pharmacodynamics PD. This open-label, phase 2 randomized study includes patients with confirmed CTCL who have previously received at least two systemic therapies and have measurable disease. The purpose is to better understand how PTX-100 works and determine the optimal dosing for this patient group. PTX-100 will be given by intravenous infusion over 60 minutes on days 1 to 5 of each cycle. In the initial phase Phase 2a, participants will be randomly assigned to receive either 500 mgm2 or 1000 mgm2 doses every 14 days for four cycles, followed by a 21-day cycle for up to 18 months. In the subsequent Phase 2b, 75 participants will receive the recommended optimal dose identified from Phase 2a following the same infusion schedule. Participants will undergo a 28-day screening period before treatment begins. During the study, safety blood tests will be collected on the first day of each cycle, and detailed blood samples will be taken during the first cycle to study how PTX-100 behaves in the body. Patients will also have skin evaluations, safety exams, and quality of life questionnaires at each cycle day 1 visit. The study will continue for up to 18 months or until disease progression, unacceptable side effects, or other reasons for stopping treatment arise.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult patient 18 years of age or older at the time of signing informed consent
Capable of giving adequate signed informed consent
Confirmed diagnosis of Cutaneous T-Cell Lymphoma with histological confirmation
Disease stage greater than or equal to Stage Ib
Have received and failed or are intolerant of at least two prior systemic therapies
Measurable disease by mSWAT, flow cytometry, morphology in blood, or Lugano Criteria within 28 days prior to treatment
On stable dose of systemic corticosteroid less than 10 mg prednisone or equivalent, or stable topical corticosteroids
Completed washout period of at least 2 weeks (4 weeks for monoclonal antibodies) or 5 half-lives from prior anticancer therapy
Negative for human T-cell lymphotropic virus type 1 (HTLV1)
ECOG performance status of 0 to 2
Life expectancy of 3 months or greater
Adequate bone marrow, liver, kidney, and coagulation function
HIV-positive patients must be on stable effective antiretroviral therapy with viral load less than 400 copies/mL for at least 4 weeks
Male patients must agree to use highly effective contraception during treatment and for 3 months after
Female patients must not be pregnant or breastfeeding and either not be of childbearing potential or agree to use highly effective contraception or abstain from heterosexual intercourse during treatment and for 3 months after
Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose
Willing and able to adhere to study requirements as judged by Investigator

You will not qualify if you...

Known central nervous system involvement
Use of strong inhibitors or inducers of CYP enzymes or transporters unless discontinued for at least 14 days or 5 half-lives before starting PTX-100
Significant cardiovascular disease, interstitial lung disease, or severely impaired lung function
Active viral, bacterial, fungal, or other serious infections requiring ongoing systemic treatment (routine antimicrobial prophylaxis allowed)
History of another malignant tumor within past 5 years except treated basal or squamous cell carcinoma or carcinoma in situ with no evidence of disease
Use of immunomodulatory drugs within 4 weeks prior to baseline
Active viral hepatitis infection, except certain controlled chronic hepatitis B or cured hepatitis C as discussed with Medical Monitor
Any condition or laboratory abnormality that could confound study results or interfere with participation
Prior allogeneic or autologous hematopoietic transplantation
Known psychiatric disorder interfering with study compliance
Recent history (within 1 year) of illicit drug or alcohol abuse or dependence interfering with compliance

Research Team

Upaly Bahadure

David Wong

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