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NCT Number: NCT05863234

Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

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

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Key information

Conditions

Aggressive NK Cell Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Large Granular Lymphocytic Leukemia, Lymphoid Leukemia, T-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPMX-T003

Drug

The therapeutic agent is administered continuously intravenously

Primary outcomes

  1. Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)

    Time frame: 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.

Secondary outcomes

  1. Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)

    Time frame: From the second course to the final course (Max. 35days after the first administration)

    In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the second course or later, incidence of AEs and DLTs by the treatment are measured.

  2. Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan

    Time frame: 35 days

    As a part of efficacy evaluation of the treatment, percentage change in the product of the maximum long and short diameters of the liver measured by CT (assessed by the primary physician)

  3. Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na)

    Time frame: 35 days

  4. Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months

    Time frame: 6 months

  5. Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy

    Time frame: 35days after the treatment

  6. Serum drug concentration during repeated continuous intravenous PPMX-T003 administration

    Time frame: 35 days

  7. Anti-drug antibody production (Immunogenicity)

    Time frame: 35 days

Study contacts

Contact information is provided by the study sponsor or research team.

Kiyoshi Ando

CONTACT

[email protected]

+81 82-257-5555

Sponsors and collaborators

Lead sponsor

Hiroshima University Hospital

Other

Collaborators

  • Hokkaido University Hospital
  • Komagome Hospital
  • Kyoto University Hospital
  • Kyushu University
  • Nagoya University
  • Okayama University
  • Tohoku University
  • Tokai University

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 17, 2023
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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