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NCT02280811 · OUTCOME

Maximum Tolerated Dose (MTD)

T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers · Source last updated 2017-09-06

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

Measure
NUMBER
Unit
# of cells x 10^11
Interval / dispersion
Not reported
Time frame
participants were followed for the duration of hospital stay, an average of 3 weeks

What was measured

The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.

Groups in this outcome

All Treated Subjects

All treated subjects who received at least one dose of human papilloma virus (HPV)-16 E6 monoclonal T cell receptor (mTCR) peripheral blood lymphocytes (PBL) 1x10\^9, 1x10\^10,1x10\^11, \>1x10\^11 up to 2x10\^11 + high-dose (HD) interleukin 2 (IL-2) were included.

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

Analysis denominator · Participants

GroupSource count
All Treated Subjects10

Reported measurements

Source class 1
Values in # of cells x 10^11 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Treated Subjects2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.
groups
  1. description
    All treated subjects who received at least one dose of human papilloma virus (HPV)-16 E6 monoclonal T cell receptor (mTCR) peripheral blood lymphocytes (PBL) 1x10\^9, 1x10\^10,1x10\^11, \>1x10\^11 up to 2x10\^11 + high-dose (HD) interleukin 2 (IL-2) were included.
    id
    OG000
    title
    All Treated Subjects
param Type
NUMBER
reporting Status
POSTED
time Frame
participants were followed for the duration of hospital stay, an average of 3 weeks
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
# of cells x 10^11

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

Preserved source evidence · Not medical advice