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 Leukemia

What this Trial Is About

Researchers are conducting a Phase I/II dose-escalation study to assess the tolerability, safety, efficacy, and pharmacokinetics of PPMX-T003 in patients with aggressive NK-cell leukemia. This study aims to better understand how this investigational treatment works and its effects in this serious condition. The research is sponsored by Hiroshima University Hospital. Participants will receive PPMX-T003, administered as a continuous intravenous infusion. The study includes multiple courses of treatment, with the first course lasting 7 days and further courses up to a maximum of 35 days. The trial does not include a placebo group and is open-label, meaning both researchers and participants know the treatment being given. During the study, participants will be monitored for adverse events and dose-limiting toxicities, particularly in the first 7 days after initial administration. Efficacy will be evaluated through liver volume assessed by CT scans, liver function tests, survival duration at 6 months, and the ability to transition to chemotherapy. Blood samples will be taken to measure drug concentration and immune response. The entire participation duration includes these monitoring and assessment periods up to six months.

Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia