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NCT05451849 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
Other-event reporting threshold
0%

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

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

4 / 66 / 61 / 6

Group identifiers: EG000: Phase 1

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Serious TEAE related to TC-510
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Cytokine Release Syndrome
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Serious TEAE related to TC-510
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Pneumonitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Serious TEAE related to TC-510
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Hypoxia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
    term
    Cytokine Release Syndrome
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Hypoxia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Pleuritic Pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Pneumonitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Cough
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Dypsnoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Alanine aminotransferase increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Aspartate aminotransferas increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Lipase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Amylase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Blood alkaline phosphatase increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Platelet count decreased
Complete source fields
description
The modified ITT Population included all participants enrolled and treated with TC-510.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    6
    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
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase 1
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
    term
    Cytokine Release Syndrome
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Hypoxia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Pleuritic Pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    term
    Pneumonitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Cough
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Dypsnoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Alanine aminotransferase increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Aspartate aminotransferas increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Lipase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Amylase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Blood alkaline phosphatase increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Platelet count decreased
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Serious TEAE related to TC-510
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Cytokine Release Syndrome
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Serious TEAE related to TC-510
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    term
    Pneumonitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Serious TEAE related to TC-510
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    term
    Hypoxia
time Frame
From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)

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Preserved source evidence · Not medical advice