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NCT03483103 · OUTCOME

PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) · Source last updated 2023-12-20

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

Measure
GEOMETRIC_MEAN
Unit
day*copies/ug
Interval / dispersion
Geometric Coefficient of Variation
Time frame
From first dose to up to 24 months

What was measured

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.

Analysis population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR

Groups in this outcome

Lisocabtagene Maraleucel (JCAR017)

Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.

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

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)55

Reported measurements

Source class 1
Values in day*copies/ug · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)178631.0228.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        228.3
        value
        178631.0
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
    id
    OG000
    title
    Lisocabtagene Maraleucel (JCAR017)
param Type
GEOMETRIC_MEAN
population Description
All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR
reporting Status
POSTED
time Frame
From first dose to up to 24 months
title
PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)
type
SECONDARY
unit Of Measure
day*copies/ug

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

Preserved source evidence · Not medical advice