Participant flow

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) · Source last updated 2026-03-18

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

groups

1. description

   Participants with relapsed/refractory mantle cell lymphoma (MCL) received conditioning chemotherapy (CTE) consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg on Day 0.

   id

   FG000

   title

   2 x 10^6 Axicabtagene Ciloleucel

2. description

   Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.

   id

   FG001

   title

   Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel

3. description

   Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.

   id

   FG002

   title

   Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         6

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         3

      type

      Enrolled but never treated

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Enrolled, did not initiate AC

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         2

      type

      Full consent withdrawal

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         74

      3. group Id

         FG002

         num Subjects

         17

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         68

      3. group Id

         FG002

         num Subjects

         14

      type

      Safety Analysis Set (Treated Participants)

   3. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. comment

         Rolled over to another Long Term Follow Up (LTFU) study.

         group Id

         FG001

         num Subjects

         23

      3. comment

         Rolled over to another LTFU study.

         group Id

         FG002

         num Subjects

         5

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         51

      3. group Id

         FG002

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants from 2 x 10\^6 axicabtagene ciloleucel (AC) didn't contribute to primary and secondary analysis. The process used to manufacture axicabtagene ciloleucel was modified to manufacture brexucabtagene autoleucel (KTE-X19).

recruitment Details

Participants were enrolled at study sites in United States, France, Netherlands and Germany.

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Preserved source evidence · Not medical advice