Fig 1.
Study schedule of enrollment, interventions, and assessments.
Abbreviations: ECG: electric cardiogram; CBC: complete blood count; ECOG PS: Eastern Cooperative Oncology Group Performance Status; mMRC: modified Medical Research Council; PK/PD: pharmacokinetic/pharmacodynamic; AE: adverse event; DLT: dose limiting toxicity; HLA: human leukocyte antigen.
Fig 2.
The study outline, including all study visits and timeline.
Abbreviations: DC/Gal: dendritic cells pulsed with a-Galactosylceramide; DLT: dose limiting toxicity; iPSC-iNKT: induced pluripotent stem cell-derived invariant natural killer T.
Fig 3.
The 3 + 3 design for dose escalation.
The descriptions in the rectangles represent the actions needed. The descriptions in the diamonds represent the assessment for DLT. The numbers above the arrays represent the number of patients who have DLT. Abbreviations: DLT: dose limiting toxicity; MTD: maximum tolerable dose.
Table 1.
List of specification tests for the induced pluripotent stem cell-derived invariant natural killer T (iPSC-iNKT) cells.
Table 2.
List of specification tests for the a-galactosyl ceramide-pulsed autologous dendritic cells (DC/Gal).