Monitoring and assessment
tumor, hypersensitivity, Tumor, CRS
TUMOR, TUMOR, EVENTS, CYTOKINE RELEASE SYNDROME, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, INFLUENZA-LIKE ILLNESS, BLOOD, HYPERSENSITIVITY
Patient visits included physical exams, recording of vital signs, ECOG evaluation and ECG measurement. Tumor imaging was performed at Screening and every 9 weeks (first year) or every 12 weeks (thereafter), as assessed by the investigator per RECIST 1.1. The first 2 participants in a cohort underwent 23 h of observation after the first administration of SQZ-PBMC-HPV. All patients were observed for at least 4 h after each SQZ-PBMC-HPV administration. A blood sample for cytokine analysis was collected 30 min pre- administration and serially during the observation. Blood draws for cytokine analysis and other pharmacodynamic assessments were also taken at all subsequent visits.AEs were assessed using CTCAE version 5.0. AE of special interest (AESIs) included events suggestive of hypersensitivity, cytokine release syndrome (CRS), systemic inflammatory response syndrome, influenza-like illness, infusion-related reaction (IRR), and irAEs. In all cohorts, AEs and AESIs that developed after any administered dose had resolved to < Grade 2 at the time of subsequent administration.A baseline tumor biopsy was obtained within 28 days of the patient’s leukapheresis, and a second biopsy was collected at cycle 2 day 8. Tumor biopsies were analyzed by immunohistochemistry and/or other related techniques in a CAP/CLIA-certified laboratory using both Ventana and Leica autostainers. Brightfield and fluorescent images were digitally captured from microscope slides and analyzed by digital image analysis (HALO or Visiopharm) or Pathologist scoring. The antibodies or probes were used to identify biomarkers and changes in tumor microenvironment. Additional details for the biopsy analyses are provided in the Further details of the protocol are provided in the 