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Clinical Trials in Japan / NCT05863234
Recruiting Phase 1/2

Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

NCT05863234 · tracked via the Priya Life Science Japan tracker
Sponsor
Hiroshima University Hospital
Phase
Phase 1/2
Started
2023-09-21
Last updated
2025-04-30

Condition(s) studied

Aggressive NK Cell Leukemia

Investigational drug(s) / intervention(s)

PPMX-T003

PPMX-T003: The therapeutic agent is administered continuously intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course) — 7days after the administration
    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.

Trial sites (1)

FacilityCityRegionStatus
Hiroshima University Hospital Hiroshima Hiroshima Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05863234 on ClinicalTrials.gov ↗ ← All trials in Japan