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Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors

Study acronym: IGNYTE-ESO
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Jul 31, 2026 to Jul 31, 2028v37
  2. Re-verified, no change to tracked fieldsv36
  3. Lead sponsor: Adaptimmune to USWM CT, LLCv35
  4. Primary completion date: Sep 18, 2024 to Mar 1, 2024v34
  5. Re-verified, no change to tracked fieldsv33
Show 31 earlier versionsHide 31 earlier versions
  1. Primary completion date changed from estimate of Aug 28, 2024 to Sep 18, 2024v32
  2. Lead sponsor: GlaxoSmithKline to Adaptimmune Primary completion date: Nov 30, 2022 to Aug 28, 2024 · Study sites: 37 to 38 · Eligibility criteria expanded, about 62 wordsv31 Show 3 more changesShow less
    • Primary completion date: Nov 30, 2022 to Aug 28, 2024
    • Study sites: 37 to 38
    • Eligibility criteria expanded, about 62 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 97 to confirmed 103 · Study sites: 38 to 37v30 Show 2 more changesShow less
    • Enrollment target: estimated 97 to confirmed 103
    • Study sites: 38 to 37
  4. Enrollment target: 80 to 97 Secondary endpoints revised (14) · Study description shortened, about 1 wordv29 Show 2 more changesShow less
    • Secondary endpoints revised (14)
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 35 to 38v28
  6. Primary endpoints revised (2) Study sites: 31 to 35 · Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (lete-cel, GSK3377794) (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), Letetresgene autoleucel (lete-cel, GSK3377794) (Drug) · Secondary endpoints revised (14) · 2 morev27 Show 5 more changesShow less
    • Study sites: 31 to 35
    • Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (lete-cel, GSK3377794) (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), Letetresgene autoleucel (lete-cel, GSK3377794) (Drug)
    • Secondary endpoints revised (14)
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 30 to 31v26
  8. Study sites: 28 to 30v25
  9. Primary endpoints revised (2) Enrollment target: 65 to 80 · Study sites: 27 to 28 · Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (lete-cel, GSK3377794) (Drug) · 3 morev24 Show 6 more changesShow less
    • Enrollment target: 65 to 80
    • Study sites: 27 to 28
    • Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (lete-cel, GSK3377794) (Drug)
    • Eligibility criteria shortened, about 279 words
    • Secondary endpoints: 13 to 14
    • Study description expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 26 to 27v23
  11. Study sites: 25 to 26v22
  12. Study sites: 24 to 25v21
  13. Start date: Oct 7, 2019 to Dec 31, 2019 Study sites: 21 to 24v20 Show 1 more changeShow less
    • Study sites: 21 to 24
  14. Primary completion date: Jan 14, 2022 to Nov 30, 2022 Study sites: 15 to 21 · Completion date: Dec 15, 2025 to Jul 31, 2026 · Start date: Dec 31, 2019 to Oct 7, 2019 · 4 morev19 Show 7 more changesShow less
    • Study sites: 15 to 21
    • Completion date: Dec 15, 2025 to Jul 31, 2026
    • Start date: Dec 31, 2019 to Oct 7, 2019
    • Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), GSK3377794 (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), letetresgene autoleucel (Drug)
    • Eligibility criteria expanded, about 88 words
    • Secondary endpoints: 41 to 13
    • Study description shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 14 to 15v18
  16. Study sites: 13 to 14v17
  17. Study sites: 12 to 13v16
  18. Study sites: 11 to 12v15
  19. Study sites: 10 to 11v14
  20. Study sites: 8 to 10v13
  21. Study sites: 7 to 8v12
  22. Study sites: 5 to 7v11
  23. Study sites: 4 to 5v10
  24. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 4v9 Show 1 more changeShow less
    • Study sites: 3 to 4
  25. Start date: Nov 15, 2019 to Dec 31, 2019v8
  26. Study sites: 2 to 3v7
  27. Start date: Oct 31, 2019 to Nov 15, 2019v6
  28. Primary completion date: Apr 16, 2021 to Jan 14, 2022 Study sites: 1 to 2v5 Show 1 more changeShow less
    • Study sites: 1 to 2
  29. Start date: Sep 30, 2019 to Oct 31, 2019 Study sites: 0 to 1 · Primary completion date: Jul 15, 2021 to Apr 16, 2021v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jul 15, 2021 to Apr 16, 2021
  30. Primary completion date: Dec 15, 2025 to Jul 15, 2021v3
  31. Primary completion date: Jan 14, 2022 to Dec 15, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
Trial Details
NCT Number NCT03967223
Lead Sponsor USWM CT, LLC
Conditions Neoplasms
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov