drugset

drugset / Trial / NCT05863234

Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

NCT05863234 ↗

Phase 1/2 Recruiting 7 enrolled Hiroshima University Hospital Hokkaido University Hospital · collab Komagome Hospital · collab Kyoto University Hospital · collab Kyushu University · collab Nagoya University · collab Okayama University · collab Tohoku University · collab Tokai University · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2023-09-21
Primary completion: 2026-03-31
Completion: 2026-03-31

Publications

Fukuhara 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PPMX-T003	Monoclonal antibody	0.5 mg/kg	Intravenous
Subject	PPMX-T003	Monoclonal antibody	1 mg/kg	Intravenous
Subject	PPMX-T003	Monoclonal antibody	2 mg/kg	Intravenous

Indications