NCT02858310 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- FG000
- title
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- FG001
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- id
- FG002
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- description
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- id
- FG003
- title
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- description
- Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
- id
- FG004
- title
- Participants Enrolled But Were Not Treated
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 36
- type
- Screen failure
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 0
- comment
- Participants were enrolled, consented, not treated, and following further evaluation, considered screen failures.
- group Id
- FG004
- num Subjects
- 36
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 36
- type
- NOT COMPLETED
- title
- Phase I Dose Escalation
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 2
- type
- Disease progression before treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 133
- type
- Screen failure
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- Participant declined to participate (before treatment started).
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 5
- type
- Death On Study
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 12
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- New protocol
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 2
- type
- Lost to further follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- Not treated, other reason
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 18
- comment
- Participants were enrolled, consented, and not treated following further evaluation for reasons noted in the table
- group Id
- FG004
- num Subjects
- 158
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 18
- group Id
- FG004
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 158
- type
- NOT COMPLETED
- title
- Phase II Recommended Phase 2 Dose
- pre Assignment Details
- All enrolled participants are counted. Participants enrolled and not treated are included in the table.
Complete source fields
- groups
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- FG000
- title
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- FG001
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- id
- FG002
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- description
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- id
- FG003
- title
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- description
- Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
- id
- FG004
- title
- Participants Enrolled But Were Not Treated
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 36
- type
- Screen failure
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 0
- comment
- Participants were enrolled, consented, not treated, and following further evaluation, considered screen failures.
- group Id
- FG004
- num Subjects
- 36
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 6
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 36
- type
- NOT COMPLETED
- title
- Phase I Dose Escalation
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 2
- type
- Disease progression before treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 133
- type
- Screen failure
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- Participant declined to participate (before treatment started).
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 5
- type
- Death On Study
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 12
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- New protocol
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 2
- type
- Lost to further follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- type
- Not treated, other reason
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 18
- comment
- Participants were enrolled, consented, and not treated following further evaluation for reasons noted in the table
- group Id
- FG004
- num Subjects
- 158
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 18
- group Id
- FG004
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 158
- type
- NOT COMPLETED
- title
- Phase II Recommended Phase 2 Dose
- pre Assignment Details
- All enrolled participants are counted. Participants enrolled and not treated are included in the table.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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