N-[[(2S)-4-[(4-METHYL-1H-IMIDAZOL-5-YL)METHYL]-3-OXO-2-(PHENYLMETHYL)-1-PIPERAZINYL]CARBONYL]-L-LEUCINE TRIHYDRATE for Cutaneous T-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Adult patient ≥18 years of age\n- Patient is capable of giving adequate signed informed consent\n- Has an ECOG PS of 0 to 2.\n- Life expectancy of 3 months or greater\n- Has adequate bone marrow function as defined below: • Absolute neutrophil count (ANC) ≥ 1.0×109/L (without growth factors). • Platelet count ≥ 50×109/L • Hemoglobin ≥ 8.0 g/dL (without erythroid stimulating agents)\n- Has adequate hepatic function as defined below: •Total bilirubin ≤ 1.5 × upper limit of normal (ULN)(Patients with Gilbert’s Syndrome or hepatic involvement may be eligible at the Investigator’s discretion in consultation with the Medical Monitor if < 3 × ULN) and Alanine aminotransferase ≤ 2.5×ULN • Aspartate aminotransferase ≤ 2.5×ULN\n- Has adequate Renal function as defined below: • Creatinine Calculated or estimated creatinine clearance of ≥ 50 mL/min by Cockcroft-Gault\n- Has adequate coagulation function as defined below: • INR < 1.5 ULN • Activated partial thromboplastin time ≤ 1.5 ULN\n- Have a confirmed diagnosis of CTCL with histological confirmation of: a. Mycosis fungoides (MF) OR b. Sezary syndrome (SS) c. Other CTCL subtypes may be permitted after discussion with the medical monitor. NOTE: Histopathology confirmation of CTCL is based on ISCL/EORTC criteria\n- Patients must have greater than or equal to Stage IB disease for MF/SS subtypes. For non MF/non SS subtypes, must have at least T2 disease based on ISCL/EORTC criteria and consideration for inclusion into the study must first be discussed with the medical monitor. (ref: Olsen EA et al. Blood 140 (5); 2022)\n- Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease. Systemic therapies can include any of the following: INF-α, chemotherapy agent such as methotrexate, histone deacetylase inhibitors, antibody drug conjugates, monoclonal antibodies or a prior investigational agent.\n- Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: a. Skin lesions evaluable by mSWAT >0 (Refer to Revised International Working Group [Olsen 2022]) OR b. Atypical and/or malignant lymphocytes quantifiable by flow cytometry or morphology in blood based on Olsen 2022 staging criteria OR c. Extracutaneous disease measurable by Lugano Criteria\n- On a stable dose of systemic corticosteroid (≤10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted.\n- Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy\n- Must be human T-cell lymphotropic virus type 1 (HTLV1) negative."}

Exclusion criteria

• {"criterion_text":"- Patients with known central nervous system involvement\n- Significant cardiovascular disease including any of the following: a. Myocardial infarction within 6 months prior to signing informed consent. b. Uncontrolled angina within 3 months prior to signing informed consent. c. Congestive heart failure; New York Heart Association (NYHA) class III or IV, or a history of congestive heart failure NYHA class III or IV. d. QT interval corrected by the Fridericia correction formula (QTcF) >470 msec at screening. e. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes). f. History of Mobitz II second-degree or third-degree heart block. g. Uncontrolled hypertension as indicated by a resting systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at screening.\n- A history of, or concurrent interstitial lung disease or severely impaired lung function.\n- Active viral, bacterial, fungal infection or other serious infection requiring ongoing systemic treatment. Routine antimicrobial prophylaxis is permitted.\n- Medical history of another malignant tumor within the past 3 years. Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ who have undergone curative therapy with no evidence of disease.\n- On an immunomodulatory drug for concomitant or intercurrent conditions or who have received any of these agents within 4 weeks of baseline.\n- Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV deoxyribose nucleic acid titer < 1000 cps/mL or 200 IU/mL) may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus infection who have completed curative antiviral treatment and have a viral load below the limit of quantification may be eligible and should be discussed with the Medical Monitor.\n- A history or current evidence of any condition, laboratory abnormality or other circumstance that might confound the results of the study or interfere with patient participation for the full duration of the study\n- Prior allogeneic or autologous hematopoietic transplantation\n- Has a known psychiatric disorder that would interfere with compliance with the requirements of the study.\n- Is a consumer of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence that in the judgment of the Investigator, would interfere with compliance with the requirements of the study."}

Primary endpoints

• {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Further Efficacy: - Skin response as per Modified Severity-Weighted Assessment Tool (mSWAT) - Progression-free survival (PFS) - Duration of response (DOR) - Time to response (TTR) - Complete response rate (CRR) - Overall survival (OS) - Time to next (systemic) treatment (TTNT)","definition_or_measurement_approach":"Skin response measured as per Modified Severity-Weighted Assessment Tool (mSWAT); other listed efficacy endpoints are standard clinical endpoints (PFS, DOR, TTR, CRR, OS, TTNT) with no further definition in the provided data."}
• {"endpoint_text":"- Safety and Tolerability - Incidence, severity and nature of adverse events (AEs) - Changes from Baseline in vital signs, electrocardiogram (ECG), clinical laboratory values and Eastern Cooperative Oncology Group (ECOG) performance status (PS)","definition_or_measurement_approach":"Safety assessed by incidence, severity and nature of AEs; changes from baseline in vital signs, ECG, clinical labs and ECOG PS."}
• {"endpoint_text":"- PK: -\tPK parameters including: Cmax Tmax, Cmin, AUCtau, AUClast, AUCinf, kel, half-life (t1/2), total body CLss, Vzss, Cmax ratio (Rac-Cmax), and AUC Ratio (Rac-AUC) - Population PK model development (NCM) from data of Phase 2a and Phase 2b data - Population and individual patient PK parameters estimation","definition_or_measurement_approach":"PK parameters to be measured: Cmax, Tmax, Cmin, AUCtau, AUClast, AUCinf, kel, t1/2, CLss, Vzss, Rac-Cmax, Rac-AUC; population PK model development and estimation of population and individual PK parameters."}

France

Earliest CTIS Part Ii Submission Date

21-11-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

17

Number Of Sites

3

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

14-11-2025

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

25

Number Of Sites

3

Number Of Participants

15

Primary sponsor

Full Name

Prescient Therapeutics Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Australia

Contract research organisations

Name

Syneos Health Netherlands B.V.

Responsibilities

sponsorDuties codes: 1,12,13,5,8

Name

Resolutum Global Pty Limited

Responsibilities

sponsorDuties codes: 10,3,6,7

Name

PCI Pharma Services Germany GmbH

Responsibilities

sponsorDuties codes: 14

Name

Sherpa Clinical Packaging LLC

Responsibilities

sponsorDuties codes: 14

Name

Eresearchtechnology Inc.

Responsibilities

Central Imaging Review

Third parties

• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 1,12,13,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"Resolutum Global Pty Limited","duties_or_roles":"sponsorDuties codes: 10,3,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central Imaging Review","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"360 Biolabs Pty Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}