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NCT05451849 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer · Source last updated 2026-07-13

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
From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)

What was measured

TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event

Analysis population: The modified ITT Population included all participants enrolled and treated with TC-510.

Groups in this outcome

Phase 1

Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.

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

Analysis denominator · Participants

GroupSource count
Phase 16

Reported measurements

Participants with any TEAEs

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 16Not reportedNot reportedNot reportedNot reported
Participants with any TEAEs related to TC-510

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 16Not reportedNot reportedNot reportedNot reported
Participants with any TEAEs Grade >=3 related to TC-510

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 13Not reportedNot reportedNot reportedNot reported
Participants with any Serious TEAEs

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 14Not reportedNot reportedNot reportedNot reported
Participants with Serious TEAEs related to TC-510

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 13Not reportedNot reportedNot reportedNot reported
Subjects with any Serious TEAEs >=Grade 3 related to TC-510

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 12Not reportedNot reportedNot reportedNot reported
Participants with any Serious TEAEs with fatal outcome

TEAE Grade >= 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      title
      TEAE Grade >= 3
    title
    Participants with any TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      title
      TEAE Grade >= 3
    title
    Participants with any TEAEs related to TC-510
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      title
      TEAE Grade >= 3
    title
    Participants with any TEAEs Grade >=3 related to TC-510
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      TEAE Grade >= 3
    title
    Participants with any Serious TEAEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      title
      TEAE Grade >= 3
    title
    Participants with Serious TEAEs related to TC-510
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      TEAE Grade >= 3
    title
    Subjects with any Serious TEAEs >=Grade 3 related to TC-510
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      TEAE Grade >= 3
    title
    Participants with any Serious TEAEs with fatal outcome
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
groups
  1. description
    Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
    id
    OG000
    title
    Phase 1
param Type
COUNT_OF_PARTICIPANTS
population Description
The modified ITT Population included all participants enrolled and treated with TC-510.
reporting Status
POSTED
time Frame
From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
title
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice