Please select the outcome measures that correspond to the clinical trial below.
Title: Single Arm, Two Phase, Multicenter Clinical Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma
Brief Summary: This single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or refractory diffuse large B cell lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.


Options:
A: Objective Reaction Rates (0 to 180 days)
B: Number of Participants That Experienced Drug Related Grade 3-4 AEs (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants That Experienced Drug Related Grade 3-4 SAEs (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid (approximately up to 4 years)
C: Treatment-related adverse events (AEs) as assessed by CTCAE v4.03 (Up to 730 days after the final JCAR017 infusion); Dose-limiting toxicities of JCAR017 (28 days after first (single-dose schedule) or second (2-dose schedule) JCAR017 infusion); Objective response rate (ORR) (24 months)
D: Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators (First infusion date up to maximum duration of 32.7 months)

Answer: A