Last reviewed · How we verify
NCT06854653
An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.
Phase 2 trial testing PTX-100 in CTCL in 115 participants. Currently enrolling.
1 January 2028
Quick facts
| Lead sponsor | Prescient Therapeutics, Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 115 |
| Start date | 28 March 2025 |
| Primary completion | 1 January 2028 |
| Estimated completion | 1 June 2028 |
| Sites | 15 locations across United States, Australia, France, Italy |
Drugs / interventions tested
- PTX-100 — full drug profile →
Conditions studied
- CTCL — all drugs for CTCL →
Sponsor
Prescient Therapeutics, Ltd. — full company profile →
Who can join
18 and older, any sex, with CTCL. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06854653
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PTX-100
Trials testing the same drug.
- NCT03900442 — Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort · Phase 1 · completed
Other recruiting trials for CTCL
Currently open trials in the same condition.
- NCT03240211 — Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL · Phase 1 · active not recruiting
Other Prescient Therapeutics, Ltd. trials
Trials by the same sponsor.
- NCT03900442 — Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort · Phase 1 · completed
- NCT02930109 — A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06854653 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prescient Therapeutics, Ltd.
- Last refreshed: 28 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06854653.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing