Clinical trial · Interventional
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)
NCT05863234CI-TRIAL-00089093recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive NK Cell Leukemia | Aggressive NK-Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PPMX-T003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with PPMX-T003
- interventionNames
- Drug: PPMX-T003
Primary outcomes (1)
- measure
- Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)
- timeFrame
- 7days after the administration
- description
- In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the first course, incidence of AEs and DLTs by the treatment are measured.
Secondary outcomes (7)
- measure
- Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)
- timeFrame
- From the second course to the final course (Max. 35days after the first administration)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria. Exclusion Criteria: * Patients eligible to receive chemotherapy as treatment for ANKL
References
Publications (1)
- DERIVEDFukuhara N, Onizuka M, Kanda J, Asada N, Kato K, Ando K. Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia. BMJ Open. 2025 Jun 30;15(6):e098532. doi: 10.1136/bmjopen-2024-098532. PMID 40588385