Participant flow

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.

groups

1. 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

   FG000

   title

   Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)

2. 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

   FG001

   title

   Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)

3. 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

   FG002

   title

   Arm II (T Lymphocytes, IL-2, Surgery)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

11 participants were enrolled, but only 10 participants were assigned to an arm/group.

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

Preserved source evidence · Not medical advice