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

Inclusion Criteria:

1. 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 systemictherapy for their disease.

6. Has measurable disease defined by at least one of the following, within 28 daysprior to start of study treatment: by evaluable by mSWAT or quantifiable by flowcytometry or morphology in blood or measurable by Lugano Criteria.

7. On a stable dose of systemic corticosteroid (< 10 mg prednisone or equivalent) arepermitted. 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 virus type 1 (HTLV1) negative.

10. Has an ECOG PS of 0 to 2.

11. Life expectancy of 3 months or greater

12. Has adequate bone marrow function.

13. Has adequate hepatic function.

14. Has adequate Renal function.

15. Has adequate coagulation function.

16. Patients with Human Immunodeficiency virus (HIV) must be on established and stableeffective anti-retroviral therapy for at least 4 weeks and have an HIV viral load ofless than 400 copies/mL.

17. Male patients are eligible to participate if they agree to use a highly effectivecontraception during the treatment period and for at least 3 months after the lastdose of study treatment and refrain from donating sperm during this period.

18. Female patients are eligible to participate if they are not pregnant, notbreastfeeding, 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 (witha failure rate of < 1% per year) or be abstinent from heterosexual intercourseas their preferred method and usual lifestyle, beginning the time of informedconsent, during the treatment period and for at least 3 months after the lastdose of study treatment.

19. A WOCBP must have a negative serum pregnancy within 72 hours of the first dose ofstudy treatment.

20. Must be willing and able to adhere to the study as judged by the Investigator.

Exclusion Criteria:

1. Patients with known central nervous system involvement.

2. Patients who require the use of strong inhibitors or inducers of CYP enzymes ortransporters (e.g., CYP3A4, 2D6, 2C19) or (P-gp, BCRP, OATP1B1, OATP1B3, OAT1. OAT3,OCT2, MATE1 and MATE2-K). Patients who are receiving these medications at Screeningcan be enrolled into the trial if they discontinue them for at least 14 days or 5half-lives, whichever is longer, before they commence PTX-100. An alternativepharmacological treatment should be instituted by the treating clinician based onclinical judgement.

3. Significant cardiovascular disease. A history of, or concurrent interstitial lungdisease or severely impaired lung function.

4. Active viral, bacterial, fungal infection or other serious infection requiringongoing systemic treatment. Routine antimicrobial prophylaxis is permitted.

5. Medical history of another malignant tumor within the past 5 years. Exceptions arepatients with basal cell carcinoma of the skin, squamous cell carcinoma of the skinor carcinoma in situ who have undergone curative therapy with no evidence ofdisease.

6. On an immunomodulatory drug for concomitant or intercurrent conditions or who havereceived any of these agents within 4 weeks of baseline.

7. Patients with active viral (any etiology) hepatitis are excluded. However, patientswith serologic evidence of chronic hepatitis B virus (HBV) infection (defined by apositive hepatitis B surface antigen test and a positive anti-hepatitis core antigenantibody test) who have a viral load below the limit quantification (HBV deoxyribosenucleic acid titer < 1000 cps/mL or 200 IU/mL) and are not currently on viralsuppressive therapy may be eligible and should be discussed with the MedicalMonitor. Patients with a history of hepatitis C virus infection who have completedcurative antiviral treatment and have a viral load below the limit of quantificationmay be eligible and should be discussed with the Medical Monitor.

8. A history or current evidence of any condition, laboratory abnormality or othercircumstance that might confound the results of the study or interfere with patientparticipation for the full duration of the study.

9. Prior allogeneic or autologous hematopoietic transplantation 11. Has a knownpsychiatric disorder that would interfere with compliance with the requirements ofthe study.

10. Is a consumer of illicit or recreational drugs or has a recent history (within thelast year) of drug or alcohol abuse or dependence that in the judgment of theInvestigator, would interfere with compliance with the requirements of the study.