Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

Phase 1

Recruiting

• Conditions: Aggressive NK Cell Leukemia
• Interventions: Drug: PPMX-T003

• Registration Number: NCT05863234
• Lead Sponsor: Hiroshima University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-17
• Study Start: 2023-09-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with PPMX-T003	PPMX-T003	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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 (4) Percentage of subjects who were able to transition to chemotherapy	35days after the treatment
Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan	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)
Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months	6 months
Anti-drug antibody production (Immunogenicity)	35 days
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)	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.
Serum drug concentration during repeated continuous intravenous PPMX-T003 administration	35 days

Trial Locations

Locations (1)

Hiroshima University Hospital; 🇯🇵 Hiroshima, Japan