Actively Recruiting
A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
Led by Prescient Therapeutics, Ltd. · Updated on 2026-04-29
115
Participants Needed
15
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 the informed consent
- Able to give signed informed consent
- Confirmed diagnosis of CTCL with histological confirmation
- Disease stage Ib or higher
- Failed or intolerant to at least 2 prior systemic therapies
- Measurable disease by mSWAT, flow cytometry, morphology in blood, or Lugano Criteria within 28 days prior to treatment
- Stable dose of systemic corticosteroids (< 10 mg prednisone or equivalent) or topical corticosteroids allowed
- Completed washout period of 2 weeks (4 weeks for monoclonal antibodies) or 5 half-lives since prior anti-cancer therapy
- Negative for human T-cell lymphotropic virus type 1 (HTLV1)
- ECOG Performance Status of 0 to 2
- Life expectancy of 3 months or more
- Adequate bone marrow, liver, kidney, and coagulation function
- HIV patients must be on stable effective anti-retroviral therapy for at least 4 weeks with viral load < 400 copies/mL
- Male patients agree to use highly effective contraception during treatment and for 3 months after
- Female patients are not pregnant, not breastfeeding, and either not of childbearing potential or agree to use highly effective contraception or abstinence during treatment and for 3 months after
- Negative serum pregnancy test within 72 hours before first treatment dose
- Willing and able to follow study procedures 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 specific transporters unless discontinued 14 days or 5 half-lives before treatment
- Significant cardiovascular disease, interstitial lung disease, or severely impaired lung function
- Active serious infections requiring systemic treatment (routine prophylaxis allowed)
- History of another malignancy within past 5 years except certain skin cancers treated with no evidence of disease
- Use of immunomodulatory drugs within 4 weeks prior to baseline
- Active viral hepatitis (with exceptions discussed with Medical Monitor)
- Any condition or lab abnormality that could interfere with study results or participation
- Prior allogeneic or autologous hematopoietic transplantation
- Psychiatric disorders interfering with compliance
- Illicit drug or alcohol abuse within last year that might affect compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
David Wong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here