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NCT03054298 · BASELINE

Baseline characteristics

CAR T Cells in Mesothelin Expressing Cancers · Source last updated 2025-04-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      8
    8. group Id
      BG007
      value
      30
    units
    Participants
groups
  1. 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
    BG000
    title
    Cohort 1
  2. 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
    BG001
    title
    Cohort 2
  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
    BG002
    title
    Cohort 3
  4. 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
    BG003
    title
    Cohort 4
  5. 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
    BG004
    title
    Cohort 5
  6. 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
    BG005
    title
    Cohort 6
  7. 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
    BG006
    title
    Cohort 7
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          6
        6. group Id
          BG006
          value
          6
        7. group Id
          BG007
          value
          24
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          2
        6. group Id
          BG006
          value
          2
        7. group Id
          BG007
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          54.5
          upper Limit
          63.2
          value
          59.5
        2. group Id
          BG001
          lower Limit
          52.7
          upper Limit
          76.1
          value
          62.3
        3. group Id
          BG002
          lower Limit
          61.9
          upper Limit
          74.3
          value
          68.1
        4. group Id
          BG004
          lower Limit
          54.6
          upper Limit
          68.1
          value
          61.1
        5. group Id
          BG005
          lower Limit
          39.1
          upper Limit
          72.8
          value
          59.7
        6. group Id
          BG006
          lower Limit
          42.3
          upper Limit
          80.4
          value
          63.0
        7. group Id
          BG007
          lower Limit
          39.1
          upper Limit
          80.4
          value
          61.6
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          5
        5. group Id
          BG005
          value
          7
        6. group Id
          BG006
          value
          8
        7. group Id
          BG007
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          1
        5. group Id
          BG005
          value
          1
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          8
        6. group Id
          BG006
          value
          8
        7. group Id
          BG007
          value
          29
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          1
        7. group Id
          BG007
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          1
        7. group Id
          BG007
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          8
        6. group Id
          BG006
          value
          6
        7. group Id
          BG007
          value
          26
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          8
        6. group Id
          BG006
          value
          8
        7. group Id
          BG007
          value
          30
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Cohort 4 was permanently closed.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      8
    8. group Id
      BG007
      value
      30
    units
    Participants
groups
  1. 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
    BG000
    title
    Cohort 1
  2. 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
    BG001
    title
    Cohort 2
  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
    BG002
    title
    Cohort 3
  4. 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
    BG003
    title
    Cohort 4
  5. 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
    BG004
    title
    Cohort 5
  6. 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
    BG005
    title
    Cohort 6
  7. 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
    BG006
    title
    Cohort 7
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          6
        6. group Id
          BG006
          value
          6
        7. group Id
          BG007
          value
          24
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          2
        6. group Id
          BG006
          value
          2
        7. group Id
          BG007
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          54.5
          upper Limit
          63.2
          value
          59.5
        2. group Id
          BG001
          lower Limit
          52.7
          upper Limit
          76.1
          value
          62.3
        3. group Id
          BG002
          lower Limit
          61.9
          upper Limit
          74.3
          value
          68.1
        4. group Id
          BG004
          lower Limit
          54.6
          upper Limit
          68.1
          value
          61.1
        5. group Id
          BG005
          lower Limit
          39.1
          upper Limit
          72.8
          value
          59.7
        6. group Id
          BG006
          lower Limit
          42.3
          upper Limit
          80.4
          value
          63.0
        7. group Id
          BG007
          lower Limit
          39.1
          upper Limit
          80.4
          value
          61.6
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          5
        5. group Id
          BG005
          value
          7
        6. group Id
          BG006
          value
          8
        7. group Id
          BG007
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          1
        5. group Id
          BG005
          value
          1
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          8
        6. group Id
          BG006
          value
          8
        7. group Id
          BG007
          value
          29
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          1
        7. group Id
          BG007
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          1
        7. group Id
          BG007
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          8
        6. group Id
          BG006
          value
          6
        7. group Id
          BG007
          value
          26
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG006
          value
          0
        7. group Id
          BG007
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          8
        6. group Id
          BG006
          value
          8
        7. group Id
          BG007
          value
          30
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Cohort 4 was permanently closed.

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Preserved source evidence · Not medical advice