Clinical trial

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)

Name

PPMX-T003-CT103

Description

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 arms

Trial start

2023-04-20

Estimated PCD

2025-03-31

Trial end

2025-03-31

Status

Recruiting

Phase

Early phase I

Treatment

PPMX-T003

The therapeutic agent is administered continuously intravenously

Arms:

Treatment with PPMX-T003

Size

Primary endpoint

Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the study

35days

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ESTIMATED'}}

Updated at

2024-02-28

1 organization

1 product

1 indication

Organization

Hiroshima University Hospital

Product

PPMX-T003

Indication

Aggressive NK Cell Leukemia