NCT02360579 · OUTCOME
Safety Profile Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma · Source last updated 2026-03-25
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 Maximum 60 months What was measured Incidence, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events
Analysis population: The Safety Analysis Set is defined as patients who received the LN-144 infusion. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.
Groups in this outcome Cohort 1 Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
Cohort 2 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
Cohort 3 Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed)
Cohort 4 Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Cohort 1 23 Cohort 2 67 Cohort 3 12 Cohort 4 89
Reported measurements TEAE-Any Grade Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 23 Not reported Not reported Not reported Not reported Cohort 2 67 Not reported Not reported Not reported Not reported Cohort 3 12 Not reported Not reported Not reported Not reported Cohort 4 89 Not reported Not reported Not reported Not reported
TEAE-Grade 3/4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 23 Not reported Not reported Not reported Not reported Cohort 2 65 Not reported Not reported Not reported Not reported Cohort 3 12 Not reported Not reported Not reported Not reported Cohort 4 86 Not reported Not reported Not reported Not reported
TEAE-Grade 5 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 2 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 2 Not reported Not reported Not reported Not reported
TEAE Related to LN-144- Any Grade Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 16 Not reported Not reported Not reported Not reported Cohort 2 50 Not reported Not reported Not reported Not reported Cohort 3 8 Not reported Not reported Not reported Not reported Cohort 4 70 Not reported Not reported Not reported Not reported
TEAE Related to LN-144-Grade 3/4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 10 Not reported Not reported Not reported Not reported Cohort 2 28 Not reported Not reported Not reported Not reported Cohort 3 3 Not reported Not reported Not reported Not reported Cohort 4 32 Not reported Not reported Not reported Not reported
TEAE Related to LN-144-Grade 5 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 1 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 0 Not reported Not reported Not reported Not reported
TEAE leading to LN-144 discontinuation -Any Grade Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 2 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 0 Not reported Not reported Not reported Not reported
TEAE leading to LN-144 discontinuation- Grade 3/4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 2 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 0 Not reported Not reported Not reported Not reported
TEAE leading to LN-144 discontinuation-Grade 5 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 0 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 0 Not reported Not reported Not reported Not reported
Treatment-Emergent SAE- Any Grade Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 9 Not reported Not reported Not reported Not reported Cohort 2 23 Not reported Not reported Not reported Not reported Cohort 3 2 Not reported Not reported Not reported Not reported Cohort 4 31 Not reported Not reported Not reported Not reported
Treatment-Emergent SAE- Grade 3/4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 9 Not reported Not reported Not reported Not reported Cohort 2 22 Not reported Not reported Not reported Not reported Cohort 3 2 Not reported Not reported Not reported Not reported Cohort 4 29 Not reported Not reported Not reported Not reported
Treatment-Emergent SAE- Grade 5 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 2 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 2 Not reported Not reported Not reported Not reported
Treatment-Emergent SAE related to LN-144-Any Grade Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 2 Not reported Not reported Not reported Not reported Cohort 2 6 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 2 Not reported Not reported Not reported Not reported
Treatment-Emergent SAE related to LN-144-Grade 3/4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 2 Not reported Not reported Not reported Not reported Cohort 2 5 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 1 Not reported Not reported Not reported Not reported
Treatment-Emergent SAE related to LN-144-Grade 5 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1 0 Not reported Not reported Not reported Not reported Cohort 2 1 Not reported Not reported Not reported Not reported Cohort 3 0 Not reported Not reported Not reported Not reported Cohort 4 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 23
group Id OG001
value 67
group Id OG002
value 12
group Id OG003
value 89
title TEAE-Any Grade categories measurements
group Id OG000
value 23
group Id OG001
value 65
group Id OG002
value 12
group Id OG003
value 86
title TEAE-Grade 3/4 categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 0
group Id OG003
value 2
title TEAE-Grade 5 categories measurements
group Id OG000
value 16
group Id OG001
value 50
group Id OG002
value 8
group Id OG003
value 70
title TEAE Related to LN-144- Any Grade categories measurements
group Id OG000
value 10
group Id OG001
value 28
group Id OG002
value 3
group Id OG003
value 32
title TEAE Related to LN-144-Grade 3/4 categories measurements
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 0
group Id OG003
value 0
title TEAE Related to LN-144-Grade 5 categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 0
group Id OG003
value 0
title TEAE leading to LN-144 discontinuation -Any Grade categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 0
group Id OG003
value 0
title TEAE leading to LN-144 discontinuation- Grade 3/4 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
title TEAE leading to LN-144 discontinuation-Grade 5 categories measurements
group Id OG000
value 9
group Id OG001
value 23
group Id OG002
value 2
group Id OG003
value 31
title Treatment-Emergent SAE- Any Grade categories measurements
group Id OG000
value 9
group Id OG001
value 22
group Id OG002
value 2
group Id OG003
value 29
title Treatment-Emergent SAE- Grade 3/4 categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 0
group Id OG003
value 2
title Treatment-Emergent SAE- Grade 5 Show more (12 of 15) denoms counts
group Id OG000
value 23
group Id OG001
value 67
group Id OG002
value 12
group Id OG003
value 89
units Participants
description Incidence, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events groups
description Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
id OG000
title Cohort 1
description Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
id OG001
title Cohort 2
description Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed)
id OG002
title Cohort 3
description Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
id OG003
title Cohort 4
param Type COUNT_OF_PARTICIPANTS
population Description The Safety Analysis Set is defined as patients who received the LN-144 infusion. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.
reporting Status POSTED
time Frame Maximum 60 months
title Safety Profile
type SECONDARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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