임상시험 레이더

ORR (Overall Response Rate)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval.

Up to approximately 36 months

DCR (Disease Control Rate)

DCR, is defined as the percentage of participants with a confirmed CR, PR, or SD with minimal 12 weeks duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by independent central review per RECIST v1.1. The observed DCR will be reported along with 95% Clopper-Pearson exact confidence interval (CI). DCR will be analyzed based on PEAP and mITT populations.

Up to approximately 36 months

PFS (Progression Free Survival)

PFS, is defined as the time from the date of T-cell infusion until the earliest date of radiological PD as assessed by independent central review per RECIST v1.1, or death due to any cause. For the analysis of PFS, if the participant received subsequent anticancer therapy prior to the date of documented events, PFS will be censored at the last adequate disease assessment (e.g., assessment when visit level response was CR, PR, or SD) prior to the initiation of the new anticancer therapy. If a participant does not have an adequate post-baseline disease assessment that is no later than the date of initiation of anti-cancer therapy, PFS will be censored at the date of the T-cell infusion date.

Up to approximately 54 months

OS (Overall survival)

OS is defined as the interval of time between the date of T-cell infusion and the date of death due to any cause. For participants who do not die, time of death will be censored at the date of last contact. The date of death should be taken from that recorded on the Record of Death page. Death on study due to any cause will be included. Survival will be listed and summarized using Kaplan-Meier quartile estimates along with 2-sided 95% CI.

up to 15 years post-T-cell infusion

DOR (Duration of response)

DOR is defined as, in the subset of participants who show a confirmed CR or PR as assessed by independent central review per RECIST v1.1, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death. Duration of response will be summarized descriptively, if data warrant, using Kaplan-Meier medians and quartiles. Censoring: same as PFS censorship table.

Up to approximately 54 months

TTR (Time to response)

TTR is defined as the time from the date of T-cell infusion to initial date of confirmed response (PR or CR) as assessed by independent central review per RECIST v1.1 in the subset of participants who achieved a confirmed PR or CR. TTR will be listed and summarized descriptively using median and quartiles in the subset of participants with a confirmed response of PR or CR. Efficacy listings such as BOR, DOR, PFS and OS will be reported for the PEAP and mITT populations.

Up to approximately 54 months

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

Up to approximately 54 months

Number of Participants with AEs of Special Interest (AESIs)

An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days.

Up to approximately 54 months

Number of Participants with TEAEs and TESAEs by Severity

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs and SAEs were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE.

Up to approximately 54 months

Number of Participants with AESIs by Severity

An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days.

Up to approximately 54 months

Percentage of Participants with Replication Competent Lentivirus (RCL) Positive

RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).

Up to approximately 54 months

Instances of Insertional Oncogenesis (IO)

Instances of Insertional Oncogenesis (IO) was summarized descriptively

Up to approximately 54 months

Maximum Transgene Expansion (Cmax)

Cmax was defined as maximum observed persistence, determined directly from the persistence-time data. Blood samples were collected for PK analysis

Day 1 to Day 14

Time to Cmax (Tmax)

Tmax was defined as time to reach Cmax, determined directly from the persistence-time data. Blood samples were collected for PK analysis.

Day 1 to Day 14

Area Under the Time Curve from Zero to Time 28 Days (AUC [0-28])

Area under the persistence-time curve from time zero to Day 28. Blood samples were collected for PK analysis.

Up to 28 days