Clinical assessments
tumor, death, toxicities, encephalopathy, PD, Laboratory anomalies
RECURRENCE, DISEASE, TUMOR, ENCEPHALOPATHY
Laboratory anomalies were screened by hematology testing, coagulation assay, serum chemistries, cytokine levels and urinalysis. Physical exams including 12-lead electrocardiograms and vital signs were performed daily during hospitalization periods for assessment of toxicities, including assessment of the immune effector cell encephalopathy score. Treatment responses were monitored by disease marker evaluation, measurement of serum cytokines, and assessment of tumor responses according to RECIST 1.1 (including time from first objective response to first occurrence of objective progression, recurrence, or death from any cause) using unidimensional measurement such as a CT scan or magnetic resonance imaging during pretreatment screening (average 5.9 weeks before ACT), at six weeks post-CLDN6 CAR-T cell infusion, then every six weeks for 50 weeks and then every 12 weeks thereafter. All patients had at least one tumor assessment post treatment, except for a treated patient who died before the first CT scan and was classified as PD.