A Phase 1/2 interventional study of PPMX-T003 in Aggressive NK Cell Leukemia, sponsored by Hiroshima University Hospital. Recruiting at 1 site in Japan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Hiroshima University Hospital · Phase 1/2, Interventional, and Treatment
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
144 studies on the registry are indexed under Leukemia, Large Granular Lymphocytic; 19 are open to participants now.
This study's planned enrollment of 7 is below the median of 37 across 102 interventional studies indexed under Leukemia, Large Granular Lymphocytic.
Browse Leukemia, Large Granular Lymphocytic studies →This is the only study on the registry with Hiroshima University Hospital as lead sponsor.
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Exclusion Criteria:
Drug: PPMX-T003
The therapeutic agent is administered continuously intravenously
Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)
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.
Time frame: 7days after the administration
Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)
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.
Time frame: From the second course to the final course (Max. 35days after the first administration)
Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan
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)
Time frame: 35 days
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)
Time frame: 35 days
Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months
Time frame: 6 months
Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy
Time frame: 35days after the treatment
Serum drug concentration during repeated continuous intravenous PPMX-T003 administration
Time frame: 35 days
Anti-drug antibody production (Immunogenicity)
Time frame: 35 days
Started Sep 2023 (actual). Primary completion is estimated for Mar 2026, 30 months after the start.
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Leukemia, Large Granular Lymphocytic →