Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03484702 · FLOW

Participant flow

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27

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

groups
  1. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG000
    title
    Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
  2. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG001
    title
    Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
  3. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG002
    title
    Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
  4. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG003
    title
    Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
  5. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG004
    title
    Cohort 5: Primary Central Nervous System Lymphoma
  6. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG005
    title
    Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        11
      comment
      Underwent Leukapheresis
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Pre-Treatment Period - Leukapheresis
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant Withdrew from Study
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        10
      comment
      Started lymphodepleting chemotherapy.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        9
      comment
      Received conforming JCAR017 cell product.
      type
      JCAR017 Treated Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        24
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        9
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
During the pretreatment period participants underwent leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants entered the treatment period and received lymphodepleting chemotherapy followed by infusion of JCAR017. Cohort 6 was planned but subsequently removed from the study. No participants were enrolled into Cohort 6.
Complete source fields
groups
  1. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG000
    title
    Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
  2. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG001
    title
    Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
  3. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG002
    title
    Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
  4. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG003
    title
    Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
  5. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG004
    title
    Cohort 5: Primary Central Nervous System Lymphoma
  6. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    FG005
    title
    Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        11
      comment
      Underwent Leukapheresis
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Pre-Treatment Period - Leukapheresis
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant Withdrew from Study
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        10
      comment
      Started lymphodepleting chemotherapy.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        9
      comment
      Received conforming JCAR017 cell product.
      type
      JCAR017 Treated Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        24
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        9
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
During the pretreatment period participants underwent leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants entered the treatment period and received lymphodepleting chemotherapy followed by infusion of JCAR017. Cohort 6 was planned but subsequently removed from the study. No participants were enrolled into Cohort 6.

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

Preserved source evidence · Not medical advice