Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 70

Evaluating the safety of PPMX-T003 for aggressive NK-cell leukemia

Official title: 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)

Run by Hiroshima University Hospital · NCT05863234 · Data updated 2026-11-12

This study is testing a new drug called PPMX-T003 to see if it is safe and effective for people with aggressive NK-cell leukemia.

More Aggressive NK Cell Leukemia trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment7 (estimated)
SponsorHiroshima University Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Hiroshima, Hiroshima)
StatusRecruiting
StartedSeptember 21, 2023
Main results expectedMarch 31, 2026
Study endsMarch 31, 2026
Registry record updatedApril 30, 2025
Trial IDNCT05863234 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with aggressive NK-cell leukemia who are not eligible for chemotherapy.

Probably not a fit

Patients who are eligible to receive chemotherapy for their aggressive NK-cell leukemia may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I/II dose-escalation study designed to assess the tolerability, safety, efficacy, and pharmacokinetics of the investigational drug PPMX-T003 in patients with aggressive NK-cell leukemia. The study will include patients diagnosed with this condition, regardless of whether it is their first occurrence or a recurrence. The trial aims to gather data on how well the drug works and its safety profile in this specific patient population.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from aggressive NK-cell leukemia.

How similar studies have gone: While this approach is being evaluated in this specific context, similar studies have shown promise in treating other forms of leukemia with novel therapies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Hiroshima University Hospital
    Hiroshima, Hiroshima, Japan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.