Participant flow

CAR T Cells in Mesothelin Expressing Cancers · Source last updated 2025-04-29

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

groups

1. description

   Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG000

   title

   Cohort 1

2. description

   Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG001

   title

   Cohort 2

3. description

   PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG002

   title

   Cohort 3

4. description

   PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG003

   title

   Cohort 4

5. description

   Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG004

   title

   Cohort 5

6. description

   Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG005

   title

   Cohort 6

7. description

   Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

   id

   FG006

   title

   Cohort 7

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         8

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         6

      type

      COMPLETED

   3. achievements

      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

         0

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Protocol specifies that a consented participant is an enrolled participant. 65 participants were consented. Of these, 34 were ineligible and 31 were eligible. Of the 31 eligible, one participant was never assigned to a cohort. This participant was withdrawn prior to assignment due to disease progression. The remaining 30 participants are detailed below.

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

Preserved source evidence · Not medical advice