RecruitingPhase 1Phase 2NCT05863234
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
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)
Sponsor
Hiroshima University Hospital
Enrollment
7 participants
Start Date
Sep 21, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria1
- 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 Criteria1
- Patients eligible to receive chemotherapy as treatment for ANKL
Interventions
DRUGPPMX-T003
The therapeutic agent is administered continuously intravenously
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05863234