CELL INTELLIGENCE · 肿瘤细胞治疗研究

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

主要终点：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. · 7days after the administration
次要终点：Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)；Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan；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)；Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months；Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy；Serum drug concentration during repeated continuous intravenous PPMX-T003 administration；Anti-drug antibody production (Immunogenicity)

• Treatment with PPMX-T003 · EXPERIMENTAL

This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.