ClinicalTrials.gov record NCT05863234

Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 70 years old
SexAll
LocationJapan
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase I/II dose-escalation study gives repeated continuous intravenous PPMX-T003 to people with aggressive NK‑cell leukemia. The main goals are to find tolerated doses and record safety and drug levels. The study also collects early measures of efficacy such as liver changes, 6‑month survival, and whether participants can transition to chemotherapy.

What it is studying. Whether repeated continuous intravenous PPMX-T003 is tolerable and safe, and to measure its pharmacokinetics and early signals of efficacy in aggressive NK‑cell leukemia.

What the researchers hope to learn. To evaluate tolerability and safety (including adverse events and dose-limiting toxicities), to measure pharmacokinetics (serum drug concentration), to assess immunogenicity (anti-drug antibodies), and to collect early efficacy data such as liver measurements, liver-function scores, 6-month survival, and the proportion able to transition to chemotherapy.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • PPMX-T003

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive repeated continuous intravenous infusions of the study drug PPMX-T003 in a dose-escalation plan. Doctors will monitor for side effects and dose-limiting toxicities, take blood samples to measure drug levels and anti‑drug antibodies, perform CT scans to measure liver size, and assess liver function using MELD and MELD‑Na scores. Safety is followed closely after the first treatment (including assessments within about 7 days) and over later courses (monitoring up to about 35 days after the first administration); survival is tracked to 6 months.

How the study is structured. An open-label, single-group Phase I/II dose-escalation trial in which all participants receive continuous IV PPMX-T003. The study focuses on safety and dose-finding, while also measuring drug concentrations and early efficacy outcomes over treatment courses.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Aggressive NK Cell Leukemia. Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Japan. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Sep 21, 2023
Primary completion
Mar 31, 2026 (estimated)
Study completion
Mar 31, 2026 (estimated)
Target enrollment
7 participants (estimated)
Last updated on registry
Apr 30, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Hiroshima University Hospital
Collaborators
  • Kyoto University Hospital
  • Hokkaido University Hospital
  • Okayama University
  • Tokai University
  • Kyushu University
  • Tohoku University
  • Nagoya University
  • Komagome Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Dose-Escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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