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NCT02601313 · OUTCOME

Maximum Number of CAR T Cells Measured Post-infusion

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.

Measure
MEAN
Unit
cells/μL
Interval / dispersion
Standard Deviation
Time frame
Up to Month 24

Analysis population: Participants from the Safety Analysis Set were analyzed.

Groups in this outcome

Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel

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 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.

Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel68
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel14

Reported measurements

Source class 1
Values in cells/μL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel313.02586.17Not reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel96.69109.33Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        586.17
        value
        313.02
      2. group Id
        OG001
        spread
        109.33
        value
        96.69
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      14
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. 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 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
    OG000
    title
    Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
  2. 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
    OG001
    title
    Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
param Type
MEAN
population Description
Participants from the Safety Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Up to Month 24
title
Maximum Number of CAR T Cells Measured Post-infusion
type
SECONDARY
unit Of Measure
cells/μL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice