Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Single Center, Non-randomized Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Refractory Diffuse Large B-cell Lymphoma
Brief Summary: The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL


Options:
A: Dose-limiting toxicity (DLT) (28 days)
B: Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 4 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 5 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Number of Participants With Adverse Events in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion); Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion)
C: Number of Adverse Events After CAR 20/19-T Cell Infusion (28 days after infusion)
D: Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) (First infusion date of axicabtagene ciloleucel up to 30 days); Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)); Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)); Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)); Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)); Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years))

Answer: A