An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.
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.
• Adult patient ≥18 years of age at the time of signing the informed consent.
• Patient is capable of giving adequate signed informed consent
• Have a confirmed diagnosis of CTCL with histological confirmation
• Patients must have greater than or equal to Stage Ib disease.
• Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease.
• 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.
• On a stable dose of systemic corticosteroid (\< 10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted.
• Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy.
• Must be human T-cell lymphotropic virus type 1 (HTLV1) negative.
⁃ Has an ECOG PS of 0 to 2.
⁃ Life expectancy of 3 months or greater
⁃ Has adequate bone marrow function.
⁃ Has adequate hepatic function.
⁃ Has adequate Renal function.
⁃ Has adequate coagulation function.
⁃ Patients with Human Immunodeficiency virus (HIV) must be on established and stable effective anti-retroviral therapy for at least 4 weeks and have an HIV viral load of less than 400 copies/mL.
⁃ Male patients are eligible to participate if they agree to use a highly effective contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
⁃ Female patients are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
‣ Not a woman of childbearing potential (WOCBP).
‣ OR
‣ A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle, beginning the time of informed consent, during the treatment period and for at least 3 months after the last dose of study treatment.
⁃ A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment.
⁃ Must be willing and able to adhere to the study as judged by the Investigator.