CTCLPhase 2NCT06854653
A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
A Phase 2 study testing PTX-100 in people with CTCL, run by Prescient Therapeutics, Ltd. at 15 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTCL
- What is being tested?
- PTX-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 28 Mar 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 23Show fewer
- 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.
Who cannot join
- Patients with known central nervous system involvement.
- Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (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 Screening can be enrolled into the trial if they discontinue them for at least 14 days or 5 half-lives, whichever is longer, before they commence PTX-100. An alternative pharmacological treatment should be instituted by the treating clinician based on clinical judgement.
- Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function.
- 5. Active viral, bacterial, fungal infection or other serious infection requiring ongoing systemic treatment. Routine antimicrobial prophylaxis is permitted.
- 6. Medical history of another malignant tumor within the past 5 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.
- 7. On an immunomodulatory drug for concomitant or intercurrent conditions or who have received any of these agents within 4 weeks of baseline.
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- 8. 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) and are not currently on viral suppressive therapy 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.
- 9. 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.
- 10. Prior allogeneic or autologous hematopoietic transplantation 11. Has a known psychiatric disorder that would interfere with compliance with the requirements of the study.
- 12. 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.
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
David Wong contact
15 sites in 4 countries
United States6 sites, 5 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 022155450
+1 877-442-3324
Eric Jacobsen, MD
- Recruiting
City of Hope Comprehensive Cancer Cente
Duarte, California, 91010
Linda Devine, +1 800-826-4673
Christiane Querfeld, MD, PhD
- Completed
University of California Irvine
Irvine, California, 92697
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
203-785-4095
Francine M Foss, MD
- Recruiting
Virginia Commonwealth University Massey Comprehensive Cancer Cente
Richmond, Virginia, 980037
804-828-7999
Bruce Hough, MD
- Recruiting
Rochester Skin Lymphoma Medical Group. PLLC
Rochester, New York, 14642
Brian Poligone, MD, PhD, 585-364-1188, bpoligone@roclymphoma.com
Brian Poligone, MD, PhD
Australia3 sites, 3 recruiting
- Recruiting
Epworth Healthcare
Melbourne, Victoria, 3002
Ashna Saini, 61 (03)9483 6039, Ashna.saini@epworth.org.au
Miles Prince, MD
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
61 1300 546 327
Dejan Radeski, MD
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
61 (02) 8890 5555
Ian Bilmon, MD
France3 sites, 3 recruiting
- Not yet recruiting
CHU de Bordeaux - Hopital Saint André
Bordeaux, Bordeaux, 33000
+33 5 56 79 56 79
Marie Beylot-Barry, MD, PhD
- Not yet recruiting
Hopital Lyon Sud
Lyon, Pierre-Benite, 69310
+33 4 78 86 16
Stephane Dalle, MD, PhD
- Not yet recruiting
Hopital Saint Louis
Paris, Île-de-France Region, 75010
+33 1 42 49 49 49
Adele De Masson, MD
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
Bologna, Bologna, 40138
+39 051 214 1111
Pier Luigi Zinzani, MD
- Recruiting
Universita degli Studi Di Brescia-Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Brescia, 25123
+39 030 39951
Alessandra Tucci, MD
- Recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Milano, 20132
+39 02 26431
Andres M J J. Ferreri, MD
About this study
Official title: 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.
Read the detailed description
PTX-100 from a Phase I study shown to help some CTCL patients. This Phase II study will be conducted in a larger population size and there will be initially two groups/arms in the first phase called Phase 2a. This phase will randomize and enroll 20 subjects into the 500 mg/m2 and 20 subjects into the 1000 mg/m2 PTX treatment arms. After determining the recommended optimal dose from phase 2a, for Phase 2b, 75 subjects will then be allocated into this single arm part of the study.
Once subject has signed the informed consent, subject will undergo a 28 day screening period, where eligibility would be determined. Once subject is eligible, subject will be dosed with IP. Safety bloods will be taken on the first day of every cycle. Pharmacokinetics (PKs) which are blood samples sent to the Sponsors associated laboratory and will be analysed on how PTX-100 interacts biologically. PKs will be taken on Cycle1Day1(C1D1) to C1D5 and C1D8 for the first 4 cycles. Subject will also undergo skin evaluation and safety exams at every Cycle Day 1. Subjects will also complete quality of life questionnaires at every Cycle Day1. Subjects will be on the study for 18months, until disease progression, unacceptable toxicity, participant or Investigator decision, or until study treatment discontinuation criteria are met, whichever occurs first.
- Conditions
- CTCL
- Being tested
- PTX-100
- Keywords
- Relapsed or refractory Cutaneous T Cell Lymphoma, CTCL, PTX-100, Mycosis Fungoides, Sezary Syndrome, T Cell Lymphoma, Non-Hodgkin Lymphoma, Cutaneous Lymphoma
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-100Drug
Peptidomimetic inhibitor of GGTase 1
| Study group | Role | What they receive |
|---|---|---|
| Phase 2a PTX-100 500mg/m2 | Experimental | Phase 2a PTX-100 will be 500mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months. Receives: Drug: PTX-100 |
| Phase 2a PTX-100 1000mg/m2 | Experimental | Phase 2a PTX-100 will be 1000mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months. Receives: Drug: PTX-100 |
| Phase 2b PTX-100 Recommended Optimal Dose (ROD). | Experimental | Phase 2b PTX-100 will be the Recommended Optimal Dose form Phase 2a and follow the same infusion timeline outlined previously. IV infusion of RD over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles then followed by IV infusion of RD over 60 minutes on days 1 to 5 of a 21-day cycle up to 18months. Receives: Drug: PTX-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of PTX-100 as determined by ORR.
Objective response rate (ORR): ORR is defined as the proportion of patients who achieved CR or PR as their best response
Measured: 18 months from day of first treatment until disease progression, unacceptable toxicity, participant or Investigator decision.
Secondary outcomes (10)
To further characterize the efficacy of PTX-100
Skin response as per Modified Severity-Weighted Assessment Tool (mSWAT). The mSWAT uses body surface area in 12 body areas to calculate involvement. A weighting factor is also used: Patches, which are flat, earned a multiplier of one. Plaques, which are raised, earned a multiplier of two. Tumors, which are larger and solid, earned a multiplier of three. Lesion BSA multiplied with the weighting factor with the sum of regions affected gives a final mSWAT score.
The SWAT result is a number is monitored over time. A stable number suggested a stable condition. A lower number suggested less active CTCL and conversely, a higher number suggested more active CTCL.
Measured: Within 18 months after PTX-100 initial dose.
Progression-free survival (PFS)
Defined as the time from the date of PTX-100 initiation to the date of first documented progression or death.
Measured: Within 18 months after PTX-100 initial dose.
Time to response (TTR)
TTR: defined as the time from the date of PTX-100 initiation to first confirmed objective response (CR or PR)
Measured: Within 18 months after PTX-100 initial dose.
Overall survival (OS)
OS: defined as the time interval between the date of PTX-100 initiation and the date of death due to any cause
Measured: Within 18 months after PTX-100 initial dose.
Duration of response (DoR)
DoR: defined as the time interval between the first confirmed objective response (CR or PR) and the first occurrence of objective progression (PD) or death from any cause.
Measured: Within 18 months after PTX-100 initial dose.
Complete response rate (CRR)
Complete response rate (CRR) evaluated according to the Lugano2014 criteria.
Measured: Within 18 months after PTX-100 initial dose.
Pharmacokinetics (PK) of PTX-100: Cmax
PTX-100 peak plasma concentration (Cmax) in plasma
Measured: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Pharmacokinetics (PK) of PTX-100: Tmax
Time to peak drug concentration in plasma (Tmax)
Measured: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Pharmacokinetics (PK) of PTX-100: Cmin
Cmin for the minimum blood plasma concentration reached by PTX-100 during the time interval between administration of two doses
Measured: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Pharmacokinetics (PK) of PTX-100: AUCtau
AUCtau, area under the curve from time 0 to time tau (the dosing interval) at steady state. AUCtau is typically expressed in units of concentration multiplied by time (e.g., ng·h/mL)
Measured: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start28 Mar 2025
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised parallel recruitment into 2 treatment arms, 500mg/m2 and 1000-mg/m2 for Phase 2a. Phase 2b will be non-randomised and are single arm treatment group. The recommended optimal dose which was determined in Phase 2a will be used in Phase 2b.
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prescient Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854653
- Sponsor's protocol ID
- PTX-100-02-2024
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT06854653
- Acronym / sponsor ID
- PTX-100-02-2024
- Conditions
- CTCL
- Keywords
- Relapsed or refractory Cutaneous T Cell Lymphoma, CTCL, PTX-100, Mycosis Fungoides, Sezary Syndrome, T Cell Lymphoma, Non-Hodgkin Lymphoma, Cutaneous Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Prescient Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PTX-100 from a Phase I study shown to help some CTCL patients. This Phase II study will be conducted in a larger population size and there will be initially two groups/arms in the first phase called Phase 2a. This phase will randomize and enroll 20 subjects into the 500 mg/m2 and 20 subjects into the 1000 mg/m2 PTX treatment arms. After determining the recommended optimal dose from phase 2a, for Phase 2b, 75 subjects will then be allocated into this single arm part of the study.
Once subject has signed the informed consent, subject will undergo a 28 day screening period, where eligibility would be determined. Once subject is eligible, subject will be dosed with IP. Safety bloods will be taken on the first day of every cycle. Pharmacokinetics (PKs) which are blood samples sent to the Sponsors associated laboratory and will be analysed on how PTX-100 interacts biologically. PKs will be taken on Cycle1Day1(C1D1) to C1D5 and C1D8 for the first 4 cycles. Subject will also undergo skin evaluation and safety exams at every Cycle Day 1. Subjects will also complete quality of life questionnaires at every Cycle Day1. Subjects will be on the study for 18months, until disease progression, unacceptable toxicity, participant or Investigator decision, or until study treatment discontinuation criteria are met, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised parallel recruitment into 2 treatment arms, 500mg/m2 and 1000-mg/m2 for Phase 2a. Phase 2b will be non-randomised and are single arm treatment group. The recommended optimal dose which was determined in Phase 2a will be used in Phase 2b.
| Arm | Type | Receives |
|---|---|---|
| Phase 2a PTX-100 500mg/m2 | Experimental | Drug: PTX-100Phase 2a PTX-100 will be 500mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months. |
| Phase 2a PTX-100 1000mg/m2 | Experimental | Drug: PTX-100Phase 2a PTX-100 will be 1000mg/m2 IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles. This is then followed by IV infusion over 60 minutes on days 1 to 5 of a 21-day cycle for up to 18months. |
| Phase 2b PTX-100 Recommended Optimal Dose (ROD). | Experimental | Drug: PTX-100Phase 2b PTX-100 will be the Recommended Optimal Dose form Phase 2a and follow the same infusion timeline outlined previously. IV infusion of RD over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles then followed by IV infusion of RD over 60 minutes on days 1 to 5 of a 21-day cycle up to 18months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients with known central nervous system involvement.
- Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (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 Screening can be enrolled into the trial if they discontinue them for at least 14 days or 5 half-lives, whichever is longer, before they commence PTX-100. An alternative pharmacological treatment should be instituted by the treating clinician based on clinical judgement.
- Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function.
- 5. Active viral, bacterial, fungal infection or other serious infection requiring ongoing systemic treatment. Routine antimicrobial prophylaxis is permitted.
- 6. Medical history of another malignant tumor within the past 5 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTX-100Peptidomimetic inhibitor of GGTase 1 | Drug | Phase 2a PTX-100 1000mg/m2, Phase 2a PTX-100 500mg/m2, Phase 2b PTX-100 Recommended Optimal Dose (ROD). |
Primary outcome
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
10 secondary outcomes
To further characterize the efficacy of PTX-100
Time frame: Within 18 months after PTX-100 initial dose.
Progression-free survival (PFS)
Time frame: Within 18 months after PTX-100 initial dose.
Time to response (TTR)
Time frame: Within 18 months after PTX-100 initial dose.
Overall survival (OS)
Time frame: Within 18 months after PTX-100 initial dose.
Duration of response (DoR)
Time frame: Within 18 months after PTX-100 initial dose.
Complete response rate (CRR)
Time frame: Within 18 months after PTX-100 initial dose.
Pharmacokinetics (PK) of PTX-100: Cmax
Time frame: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Pharmacokinetics (PK) of PTX-100: Tmax
Time frame: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Pharmacokinetics (PK) of PTX-100: Cmin
Time frame: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Pharmacokinetics (PK) of PTX-100: AUCtau
Time frame: Cycle 1: Day 1 and Day 5: pre-dose, 5 mins post-infusion, and at 1, 2, 4, 6, and 8 hours after dose. Day 2, 3 and 4: 24 hours after previous dose, bloods taken at Pre and at 5 mins post-infusion. Day 8; 72 hours after the Day 5 dose and prior to dosing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Wong contact
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTX-100 in people with CTCL, run by Prescient Therapeutics, Ltd. at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Upaly Bahadure (+61 3 9692 7222, upaly@ptxtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.