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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Japan
Hiroshima University Hospital
RECRUITING
Hiroshima
Contact Information
Primary
Kiyoshi Ando
andok@keyaki.cc.u-tokai.ac.jp
+81 82-257-5555
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 7
Treatments
Experimental: Treatment with PPMX-T003
Related Therapeutic Areas
Sponsors
Collaborators: Okayama University, Tokai University, Kyoto University Hospital, Nagoya University, Hokkaido University Hospital, Tohoku University, Komagome Hospital, Kyushu University
Leads: Hiroshima University Hospital