Study Procedures
tumor, fatigue, diarrhea, toxicity, autoimmune reactions, nausea,
ADVERSE EVENT, TUMOR, AUTOIMMUNE REACTIONS, ADVERSE EVENTS, ADVERSE EVENT, ELECTROLYTE DISTURBANCE, ALLERGIC REACTIONS
Safety assessments included evaluation of adverse events as per the NCI Common Terminology Criteria for Adverse Events version 4.03. Adverse event assessment was performed at the following timepoints: at each infusion; on day +1 following the first infusion; on the date of tumor resection or biopsy which was on day 11 or within 3 days of last CAR T infusion; at end of treatment; at each monthly follow-up visit until 4 months after the first infusion or until alternative therapy was initiated, whichever occurred earlier. A treatment-limiting toxicity (TLT) was defined as any grade 3 non-hematologic toxicity which is new, develops following dosing within 14 days of final T-cell administration, and is at least possibly related to CAR T cells. TLTs did not include adverse events that resolved to grade 1–2 within 7 days, electrolyte disturbances, nausea, vomiting, diarrhea, or fatigue. TLTs did include grade 2 or higher autoimmune reactions and grade 3 or higher allergic reactions.Response assessments included CT or other cross-sectional imaging assessed using the RECIST version 1.1 (RECIST v1.1; ref. Research sample collection included mandatory tumor biopsy at baseline (preinfusion) and within 3 days of last CAR T-cell infusion, if feasible. Peripheral blood was collected at baseline, at each infusion, on day +1 following the first infusion, at day +25, and at each monthly follow-up visit.