Actively Recruiting
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
15
Research Sites
21 weeks
Total Duration
On this page
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 mg/m2 or 1000 mg/m2 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 18 months or until disease progression, unacceptable toxicity, participant or Investigator decision
Participants receive PTX-100 drug infusions. Initial treatment involves infusions on days 1 to 5 of a 14-day cycle for 4 cycles, followed by infusions on days 1 to 5 of a 21-day cycle for up to 18 months.
Infusions on days 1 to 5 of each cycle with safety blood tests and skin evaluations at every Cycle Day 1; pharmacokinetic blood sampling on Cycle 1 Days 1 to 5 and Day 8
Trial Site Locations
Total: 15 locations
1
City of Hope Comprehensive Cancer Cente
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 022155450
Actively Recruiting
5
Rochester Skin Lymphoma Medical Group. PLLC
Rochester, New York, United States, 14642
Actively Recruiting
6
Virginia Commonwealth University Massey Comprehensive Cancer Cente
Richmond, Virginia, United States, 980037
Actively Recruiting
7
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
8
Epworth Healthcare
Melbourne, Victoria, Australia, 3002
Actively Recruiting
9
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
10
CHU de Bordeaux - Hopital Saint André
Bordeaux, Bordeaux, France, 33000
Not Yet Recruiting
11
Hopital Lyon Sud
Lyon, Pierre-Benite, France, 69310
Not Yet Recruiting
12
Hopital Saint Louis
Paris, Île-de-France Region, France, 75010
Not Yet Recruiting
13
IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
Bologna, Bologna, Italy, 40138
Actively Recruiting
14
Universita degli Studi Di Brescia-Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Brescia, Italy, 25123
Actively Recruiting
15
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Milano, Italy, 20132
Actively Recruiting
Research Team
U
Upaly Bahadure
D
David Wong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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