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NCT01239368 · BASELINE

Baseline characteristics

Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma · Source last updated 2019-12-10

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
      2
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      0
    9. group Id
      BG008
      value
      1
    10. group Id
      BG009
      value
      5
    11. group Id
      BG010
      value
      31
    units
    Participants
groups
  1. description
    1x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG000
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. description
    5x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG001
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. description
    1x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG002
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. description
    3x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG003
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG004
    title
    Cohort 5 - 5x10(6) T Cells/kg
  6. description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
    id
    BG005
    title
    Cohort 5B - 5x10(6) T Rapa Cells/kg
  7. description
    15x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG007
    title
    Cohort 7 - 45x10(6) T Cells/kg
  9. description
    Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
    id
    BG008
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. description
    Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Th1/TC1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
    id
    BG009
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
  11. description
    Total of all reporting groups
    id
    BG010
    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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          20
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          11
        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
          spread
          13.58
          value
          45.4
        2. group Id
          BG001
          spread
          0
          value
          41.3
        3. group Id
          BG002
          spread
          0
          value
          65.8
        4. group Id
          BG003
          spread
          15.56
          value
          46.7
        5. group Id
          BG004
          spread
          13.79
          value
          58.19
        6. group Id
          BG005
          spread
          6.18
          value
          57.64
        7. group Id
          BG006
          spread
          9.58
          value
          59.29
        8. group Id
          BG008
          spread
          0
          value
          66.9
        9. group Id
          BG009
          spread
          9.08
          value
          63.6
        10. group Id
          BG010
          spread
          11.65
          value
          55.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          4
        10. group Id
          BG010
          value
          18
        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
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          1
        10. group Id
          BG010
          value
          13
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          6
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          4
        10. group Id
          BG010
          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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          value
          0
        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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          1
        10. group Id
          BG010
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          5
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          3
        10. group Id
          BG010
          value
          21
        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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          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
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          1
        10. group Id
          BG010
          value
          5
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          7
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          5
        10. group Id
          BG010
          value
          31
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      0
    9. group Id
      BG008
      value
      1
    10. group Id
      BG009
      value
      5
    11. group Id
      BG010
      value
      31
    units
    Participants
groups
  1. description
    1x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG000
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. description
    5x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG001
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. description
    1x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG002
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. description
    3x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG003
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG004
    title
    Cohort 5 - 5x10(6) T Cells/kg
  6. description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
    id
    BG005
    title
    Cohort 5B - 5x10(6) T Rapa Cells/kg
  7. description
    15x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    BG007
    title
    Cohort 7 - 45x10(6) T Cells/kg
  9. description
    Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
    id
    BG008
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. description
    Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Th1/TC1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
    id
    BG009
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
  11. description
    Total of all reporting groups
    id
    BG010
    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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          20
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          11
        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
          spread
          13.58
          value
          45.4
        2. group Id
          BG001
          spread
          0
          value
          41.3
        3. group Id
          BG002
          spread
          0
          value
          65.8
        4. group Id
          BG003
          spread
          15.56
          value
          46.7
        5. group Id
          BG004
          spread
          13.79
          value
          58.19
        6. group Id
          BG005
          spread
          6.18
          value
          57.64
        7. group Id
          BG006
          spread
          9.58
          value
          59.29
        8. group Id
          BG008
          spread
          0
          value
          66.9
        9. group Id
          BG009
          spread
          9.08
          value
          63.6
        10. group Id
          BG010
          spread
          11.65
          value
          55.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          4
        10. group Id
          BG010
          value
          18
        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
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          1
        10. group Id
          BG010
          value
          13
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          6
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          4
        10. group Id
          BG010
          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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          value
          0
        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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          1
        10. group Id
          BG010
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          5
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          3
        10. group Id
          BG010
          value
          21
        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
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          0
        10. group Id
          BG010
          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
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG008
          value
          0
        9. group Id
          BG009
          value
          1
        10. group Id
          BG010
          value
          5
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          7
        8. group Id
          BG008
          value
          1
        9. group Id
          BG009
          value
          5
        10. group Id
          BG010
          value
          31
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice