NCT06854653 · Prescient Therapeutics, Ltd.
A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
What this study is about
This is an where both patients and doctors know the treatment given, phase 2 randomly assigned study to evaluate the effectiveness, safety, how the drug moves through the body (PK) and pharmadynamics (PD), of PTX-100 treatment given alone at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL).
View original scientific description
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.
Interventions
DRUG
PTX-100
Peptidomimetic inhibitor of GGTase 1
Primary outcome measures
To determine the efficacy of PTX-100 as determined by ORR.
Time frame: 18 months from day of first treatment until disease progression, unacceptable toxicity, participant or Investigator decision.
Objective response rate (ORR): ORR is defined as the proportion of patients who achieved CR or PR as their best response
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patient ≥18 years of age at the time of signing the informed consent. 2. Patient is capable of giving adequate signed informed consent 3. Have a confirmed diagnosis of CTCL with histological confirmation 4. Patients must have greater than or equal to Stage Ib disease. 5. Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease. 6. Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: by evaluable by mSWAT or quantifiable by flow cytometry or morphology in blood or measurable by Lugano Criteria. 7. On a stable dose of systemic corticosteroid (\< 10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted. 8. Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy. 9. Must be human T-cell lymphotropic vi
Where
- Duarte, California
- Irvine, California
- New Haven, Connecticut
- Boston, Massachusetts
- Rochester, New York
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations