NCT05451849 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
- id
- FG000
- title
- Phase 1
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Did not meet eligibility criteria prior to lymphodepletion and dosing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 14
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Fourteen (14) participants were screened and subsequently underwent leukapheresis in Phase 1 (Intent-to-Treat population). Six (6) participants received lymphodepleting chemotherapy and were dosed in Phase 1 (modified Intent-to-Treat population). No participants were subsequently included in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
Complete source fields
- groups
- description
- Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
- id
- FG000
- title
- Phase 1
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Did not meet eligibility criteria prior to lymphodepletion and dosing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 14
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Fourteen (14) participants were screened and subsequently underwent leukapheresis in Phase 1 (Intent-to-Treat population). Six (6) participants received lymphodepleting chemotherapy and were dosed in Phase 1 (modified Intent-to-Treat population). No participants were subsequently included in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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