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NCT02028455 · OUTCOME

Number of Participants That Received Cetuximab Who Have T Cells Successfully Ablated

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia · Source last updated 2026-08-06

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 years

What was measured

The efficacy of cetuximab to ablate the T cells will be measured by loss of detection of T cells and any associated toxicities as well as facilitating B cell recovery.

Analysis population: Number of subjects receiving cetuximab on study for ablation of CAR T cells

Groups in this outcome

Phase 1 - Cohort 1A

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg

Phase 1-Cohort 1B

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg

Phase 1-Cohort 1C

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg

Phase 1-Cohort 1D

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg

Phase 1-Cohort 1F1

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide

Phase 1-Cohort 1F2

This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide

Phase 2

The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated

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

Analysis denominator · Participants

GroupSource count
Phase 1 - Cohort 1A0
Phase 1-Cohort 1B0
Phase 1-Cohort 1C0
Phase 1-Cohort 1D0
Phase 1-Cohort 1F10
Phase 1-Cohort 1F20
Phase 22

Reported measurements

Source class 1

Number of participants receiving cetuximab on study for ablation of CAR T cells

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 - Cohort 1A0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1B0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1C0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1D0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F10Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F20Not reportedNot reportedNot reportedNot reported
Phase 22Not reportedNot reportedNot reportedNot reported

Number of participants whose CAR T cells were successfully ablated by cetuximab administration

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 - Cohort 1A0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1B0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1C0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1D0Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F10Not reportedNot reportedNot reportedNot reported
Phase 1-Cohort 1F20Not reportedNot reportedNot reportedNot reported
Phase 20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
      title
      Number of participants receiving cetuximab on study for ablation of CAR T cells
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      title
      Number of participants whose CAR T cells were successfully ablated by cetuximab administration
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      2
    units
    Participants
description
The efficacy of cetuximab to ablate the T cells will be measured by loss of detection of T cells and any associated toxicities as well as facilitating B cell recovery.
groups
  1. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
    id
    OG000
    title
    Phase 1 - Cohort 1A
  2. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
    id
    OG001
    title
    Phase 1-Cohort 1B
  3. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
    id
    OG002
    title
    Phase 1-Cohort 1C
  4. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
    id
    OG003
    title
    Phase 1-Cohort 1D
  5. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    OG004
    title
    Phase 1-Cohort 1F1
  6. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    OG005
    title
    Phase 1-Cohort 1F2
  7. description
    The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
    id
    OG006
    title
    Phase 2
param Type
COUNT_OF_PARTICIPANTS
population Description
Number of subjects receiving cetuximab on study for ablation of CAR T cells
reporting Status
POSTED
time Frame
3 years
title
Number of Participants That Received Cetuximab Who Have T Cells Successfully Ablated
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice