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NCT02360579 · FLOW

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Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma · Source last updated 2026-03-25

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

groups
  1. description
    Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG000
    title
    Cohort 1
  2. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG001
    title
    Cohort 2
  3. description
    Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG002
    title
    Cohort 3
  4. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG003
    title
    Cohort 4
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        49
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        71
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    3. 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
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        22
      type
      Did not receive TIL
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        67
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        89
      type
      Patients Infused With TIL
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        14
      comment
      Completed refers to the number of patients who have received TIL and completed the study
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        64
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        97
      type
      NOT COMPLETED
    title
    Initial
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
        group Id
        FG001
        num Subjects
        0
      3. comment
        Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
        group Id
        FG002
        num Subjects
        12
      4. comment
        Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
        group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. 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
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Retreatment
pre Assignment Details
Cohorts 1, 2, 4 refers to the initial treatment. Cohort 3 patients had progressed following the initial treatment and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3.
Complete source fields
groups
  1. description
    Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG000
    title
    Cohort 1
  2. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG001
    title
    Cohort 2
  3. description
    Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG002
    title
    Cohort 3
  4. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
    id
    FG003
    title
    Cohort 4
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        49
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        71
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    3. 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
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        22
      type
      Did not receive TIL
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        78
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        67
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        89
      type
      Patients Infused With TIL
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        14
      comment
      Completed refers to the number of patients who have received TIL and completed the study
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        64
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        97
      type
      NOT COMPLETED
    title
    Initial
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
        group Id
        FG001
        num Subjects
        0
      3. comment
        Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
        group Id
        FG002
        num Subjects
        12
      4. comment
        Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
        group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. 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
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Retreatment
pre Assignment Details
Cohorts 1, 2, 4 refers to the initial treatment. Cohort 3 patients had progressed following the initial treatment and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3.

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Preserved source evidence · Not medical advice