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NCT02601313 · OUTCOME

Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 7.8 years

What was measured

BOR consists of (Complete response \[CR\], Partial response \[PR\], stable disease \[SD\], progressive disease \[PD\] and unknown). CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. Percentages were rounded off.

Analysis population: Participants from the mITT Analysis Set in Cohort 1 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.

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

Reported measurements

CR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel67.6Not reported55.278.5Not reported
PR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel20.6Not reported11.732.1Not reported
Stable disease
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel8.8Not reported3.318.2Not reported
Progressive disease
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel2.9Not reported0.410.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.2
        upper Limit
        78.5
        value
        67.6
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.7
        upper Limit
        32.1
        value
        20.6
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.3
        upper Limit
        18.2
        value
        8.8
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        10.2
        value
        2.9
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    units
    Participants
description
BOR consists of (Complete response \[CR\], Partial response \[PR\], stable disease \[SD\], progressive disease \[PD\] and unknown). CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. Percentages were rounded off.
dispersion Type
95% Confidence Interval
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
param Type
NUMBER
population Description
Participants from the mITT Analysis Set in Cohort 1 were analyzed.
reporting Status
POSTED
time Frame
Up to 7.8 years
title
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice