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NCT03483103 · OUTCOME

PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax

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
MEDIAN
Unit
Day
Interval / dispersion
Full Range
Time frame
From first dose to up to 24 months

What was measured

Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood 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 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)10.0Not reported622Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        22
        value
        10.0
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.
dispersion Type
Full Range
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
MEDIAN
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: Tmax
type
SECONDARY
unit Of Measure
Day

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

Preserved source evidence · Not medical advice