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NCT05194735 · FLOW

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Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors · Source last updated 2025-11-10

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

groups
  1. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
    id
    FG000
    title
    Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
  2. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
    id
    FG001
    title
    Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
  3. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
    id
    FG002
    title
    Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresed but not administered TCR-T cells due to manufacturing failure
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresed but not administered TCR-T cells due to participant developed brain metastases
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresed but not administered TCR-T cells due to early termination of study
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Cells manufactured but not infused due to participant cerebrovascular accident
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresis 1
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresis 2
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      type
      Manufacture 1
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Manufacture 2
    6. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Lymphodepletion (Enrollment)
    7. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      TCR Infusion
    8. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Assigned Dose Level 2 But Received Dose Level 1 Due to Manufacturing Process
    9. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 14 participants underwent apheresis. Per protocol, participants were considered enrolled upon meeting lymphodepletion criteria (n = 8). Six participants were not dosed due to manufacturing failure (n = 2), clinical deterioration (n = 1), or study closure prior to dosing (n = 3). BOIN accelerated dose escalation began with 1 subject at Dose Level 1; additional participants could be enrolled at safe dose levels based on manufactured cell count.
recruitment Details
34 participants signed consent forms, 14 participants were apheresed, and 8 participants were lymphodepleted and per the protocol definition were considered enrolled. 8 were treated with TCR-T cells.
Complete source fields
groups
  1. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
    id
    FG000
    title
    Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
  2. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
    id
    FG001
    title
    Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
  3. description
    Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
    id
    FG002
    title
    Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresed but not administered TCR-T cells due to manufacturing failure
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresed but not administered TCR-T cells due to participant developed brain metastases
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresed but not administered TCR-T cells due to early termination of study
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Cells manufactured but not infused due to participant cerebrovascular accident
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresis 1
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Apheresis 2
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      type
      Manufacture 1
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Manufacture 2
    6. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      Lymphodepletion (Enrollment)
    7. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      TCR Infusion
    8. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Assigned Dose Level 2 But Received Dose Level 1 Due to Manufacturing Process
    9. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 14 participants underwent apheresis. Per protocol, participants were considered enrolled upon meeting lymphodepletion criteria (n = 8). Six participants were not dosed due to manufacturing failure (n = 2), clinical deterioration (n = 1), or study closure prior to dosing (n = 3). BOIN accelerated dose escalation began with 1 subject at Dose Level 1; additional participants could be enrolled at safe dose levels based on manufactured cell count.
recruitment Details
34 participants signed consent forms, 14 participants were apheresed, and 8 participants were lymphodepleted and per the protocol definition were considered enrolled. 8 were treated with TCR-T cells.

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Preserved source evidence · Not medical advice