NCT05451849 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 6
- units
- Participants
- 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
- BG000
- title
- Phase 1
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 43
- upper Limit
- 69
- value
- 54
- title
- Mean Age
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Customized
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 6
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- MPM
- measurements
- group Id
- BG000
- value
- 2
- title
- Pancreatic
- measurements
- group Id
- BG000
- value
- 1
- title
- Ovarian
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Tumor type
- unit Of Measure
- Participants
- population Description
- The modified ITT Population included all participants enrolled and treated with TC-510.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 6
- units
- Participants
- 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
- BG000
- title
- Phase 1
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 43
- upper Limit
- 69
- value
- 54
- title
- Mean Age
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Customized
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 6
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- MPM
- measurements
- group Id
- BG000
- value
- 2
- title
- Pancreatic
- measurements
- group Id
- BG000
- value
- 1
- title
- Ovarian
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Tumor type
- unit Of Measure
- Participants
- population Description
- The modified ITT Population included all participants enrolled and treated with TC-510.
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Preserved source evidence · Not medical advice
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