NCT05863234

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Hiroshima University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

• Aggressive NK Cell Leukemia

Interventions

Type	Name	Description
DRUG	PPMX-T003	The therapeutic agent is administered continuously intravenously

Timeline

• Start date: 2023-09-21
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-05-17
• Last updated: 2025-04-30

Locations

1 site across 1 country: Japan