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NCT02215967 · FLOW

Participant flow

Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma · Source last updated 2019-10-08

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

groups
  1. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG000
    title
    0.3 x 10^6 CAR-BCMA T-cells Infused
  2. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG001
    title
    1 x 10^6 CAR-BCMA T-cells Infused
  3. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG002
    title
    3 x 10^6 CAR-BCMA T-cells Infused
  4. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG003
    title
    9 x 10^6 CAR-BCMA T-cells Infused
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Patient became ineligible for treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Patient did not get CAR T-Cells
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        19
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG000
    title
    0.3 x 10^6 CAR-BCMA T-cells Infused
  2. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG001
    title
    1 x 10^6 CAR-BCMA T-cells Infused
  3. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG002
    title
    3 x 10^6 CAR-BCMA T-cells Infused
  4. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    FG003
    title
    9 x 10^6 CAR-BCMA T-cells Infused
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Patient became ineligible for treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Patient did not get CAR T-Cells
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        19
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        16
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice