TriangleNCT03054298 · OUTCOME
Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Month 6
What was measured
Objective response rate is the proportion of subjects in the efficacy-evaluable set with radiologically confirmed measurable disease at baseline, who achieved partial response (PR) or better after infusion as determined by RECIST 1.1. Missing or non-evaluable time points will not be included. Per RECIST 1.1, a complete response is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm." A partial response is defined as "at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."
Analysis population: Cohort 4 was permanently closed.
Groups in this outcome
Cohort 1
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 2
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 3
PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 4
PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 5
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 6
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 7
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
| Group | Source count |
|---|---|
| Cohort 1 | 3 |
| Cohort 2 | 3 |
| Cohort 3 | 2 |
| Cohort 4 | 0 |
| Cohort 5 | 2 |
| Cohort 6 | 6 |
| Cohort 7 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 7 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- Objective response rate is the proportion of subjects in the efficacy-evaluable set with radiologically confirmed measurable disease at baseline, who achieved partial response (PR) or better after infusion as determined by RECIST 1.1. Missing or non-evaluable time points will not be included. Per RECIST 1.1, a complete response is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm." A partial response is defined as "at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."
- groups
- description
- Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG000
- title
- Cohort 1
- description
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG001
- title
- Cohort 2
- description
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG002
- title
- Cohort 3
- description
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG003
- title
- Cohort 4
- description
- Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG004
- title
- Cohort 5
- description
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG005
- title
- Cohort 6
- description
- Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG006
- title
- Cohort 7
- param Type
- NUMBER
- population Description
- Cohort 4 was permanently closed.
- reporting Status
- POSTED
- time Frame
- Month 6
- title
- Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice