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NCT02408016 · ADVERSE EVENTS

Adverse events

Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma · Source last updated 2021-09-13

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
12 months
Other-event reporting threshold
0%

No patients were treated in Arm II.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)

Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies

0 / 66 / 66 / 6
Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)

Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies

0 / 43 / 42 / 4
Arm II (T Lymphocytes, IL-2, Surgery)

Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection

0 / 00 / 00 / 0

Group identifiers: EG000: Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2) · EG001: Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2) · EG002: Arm II (T Lymphocytes, IL-2, Surgery)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Fever
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        6
        num Events
        9
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
        num Events
        3
      3. group Id
        EG002
        num At Risk
        0
      term
      Lymphocyte count decreased
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Hyponatremia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Dyspnea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Hypertension
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      3. group Id
        EG002
        num At Risk
        0
      term
      Anemia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        2
      3. group Id
        EG002
        num At Risk
        0
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      3. group Id
        EG002
        num At Risk
        0
      term
      White blood cell count decreased
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      3. group Id
        EG002
        num At Risk
        0
      term
      Neutrophil count decreased
    Complete source fields
    description
    No patients were treated in Arm II.
    event Groups
    1. deaths Num Affected
      6
      deaths Num At Risk
      6
      description
      Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
      id
      EG000
      other Num Affected
      6
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
    2. deaths Num Affected
      2
      deaths Num At Risk
      4
      description
      Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
      id
      EG001
      other Num Affected
      3
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
    3. deaths Num Affected
      0
      deaths Num At Risk
      0
      description
      Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Arm II (T Lymphocytes, IL-2, Surgery)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Fever
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        6
        num Events
        9
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        4
        num Events
        3
      3. group Id
        EG002
        num At Risk
        0
      term
      Lymphocyte count decreased
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Hyponatremia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Dyspnea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
        num Events
        0
      3. group Id
        EG002
        num At Risk
        0
      term
      Hypertension
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      3. group Id
        EG002
        num At Risk
        0
      term
      Anemia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        2
      3. group Id
        EG002
        num At Risk
        0
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      3. group Id
        EG002
        num At Risk
        0
      term
      White blood cell count decreased
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        4
        num Events
        1
      3. group Id
        EG002
        num At Risk
        0
      term
      Neutrophil count decreased
    time Frame
    12 months

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    Preserved source evidence · Not medical advice