NCT05863234

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

May 9, 2023

Last Update Submit

April 25, 2025

Conditions

Aggressive NK Cell Leukemia

Keywords

neoplasms

Outcome Measures

Primary Outcomes (1)

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

    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.

    7days after the administration

Secondary Outcomes (7)

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

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

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

    35 days

  • 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)

    35 days

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

    6 months

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

    35days after the treatment

  • +2 more secondary outcomes

Study Arms (1)

Treatment with PPMX-T003

EXPERIMENTAL
Drug: PPMX-T003

Interventions

PPMX-T003DRUG

The therapeutic agent is administered continuously intravenously

Treatment with PPMX-T003

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients eligible to receive chemotherapy as treatment for ANKL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40588385DERIVED

MeSH Terms

Conditions

Leukemia, Large Granular LymphocyticNeoplasms

Condition Hierarchy (Ancestors)

Leukemia, T-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Kiyoshi Ando

CONTACT

+81 82-257-5555andok@keyaki.cc.u-tokai.ac.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 17, 2023

Study Start

September 21, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations

JP(1)