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NCT03168438 · OUTCOME

Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC[0-28])

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma · Source last updated 2022-01-11

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

Measure
GEOMETRIC_MEAN
Unit
Days*Copies per microgram genomic DNA
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Up to Day 28

What was measured

Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.

Analysis population: Modified ITT Population

Groups in this outcome

GSK3377794

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.

GSK3377794+Pembrolizumab

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.

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

Analysis denominator · Participants

GroupSource count
GSK33777943
GSK3377794+Pembrolizumab3

Reported measurements

Source class 1
Values in Days*Copies per microgram genomic DNA · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
GSK3377794463989.35237.0Not reportedNot reportedNot reported
GSK3377794+Pembrolizumab1498869.2190.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        237.0
        value
        463989.35
      2. group Id
        OG001
        spread
        90.4
        value
        1498869.21
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
    id
    OG000
    title
    GSK3377794
  2. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
    id
    OG001
    title
    GSK3377794+Pembrolizumab
param Type
GEOMETRIC_MEAN
population Description
Modified ITT Population
reporting Status
POSTED
time Frame
Up to Day 28
title
Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC[0-28])
type
SECONDARY
unit Of Measure
Days*Copies per microgram genomic DNA

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

Preserved source evidence · Not medical advice