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Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv28
  2. Lead sponsor: Adaptimmune to USWM CT, LLCv27
  3. Results first posted: Jan 13, 2025 Enrollment target: 173 to 52v26 Show 1 more changeShow less
    • Enrollment target: 173 to 52
  4. Primary endpoint revised Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 120 to confirmed 173 · Study sites: 27 to 26 · 3 morev25 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 173
    • Study sites: 27 to 26
    • Primary completion date: Oct 10, 2021 to Aug 29, 2021
    • Secondary endpoints revised (13)
    • Publications: details revised at 1 of 2 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Secondary endpoints revised (13) Site details revised at 15 of 27 sitesv24 Show 1 more changeShow less
    • Site details revised at 15 of 27 sites

    See this version in full on ClinicalTrials.gov ↗

Show 22 earlier versionsHide 22 earlier versions
  1. Enrollment target: 90 to 120 Completion date: Nov 1, 2034 to Apr 1, 2038 · Eligibility criteria expanded, about 117 words · Site details revised at 8 of 27 sitesv23 Show 3 more changesShow less
    • Completion date: Nov 1, 2034 to Apr 1, 2038
    • Eligibility criteria expanded, about 117 words
    • Site details revised at 8 of 27 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Site contacts updated at 1 of 27 sitesv22
  3. Re-verified, no change to tracked fieldsv21
  4. Primary completion date changed from estimate of Jan 1, 2023 to Oct 10, 2021 Completion date: Apr 1, 2038 to Nov 1, 2034v20 Show 1 more changeShow less
    • Completion date: Apr 1, 2038 to Nov 1, 2034
  5. Completion date: Nov 1, 2034 to Apr 1, 2038 Site details revised at 10 of 27 sitesv19 Show 1 more changeShow less
    • Site details revised at 10 of 27 sites
  6. Primary completion date: May 1, 2022 to Jan 1, 2023v18
  7. Primary completion date: Oct 1, 2021 to May 1, 2022 Start date: Dec 13, 2019 to Aug 13, 2019 · Site contacts updated at 1 of 27 sitesv17 Show 2 more changesShow less
    • Start date: Dec 13, 2019 to Aug 13, 2019
    • Site contacts updated at 1 of 27 sites
  8. Re-verified, no change to tracked fieldsv16
  9. Study sites: 26 to 27 Eligibility criteria expanded, about 17 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  10. Start date: Jul 24, 2019 to Dec 13, 2019 Study sites: 25 to 26v14 Show 1 more changeShow less
    • Study sites: 25 to 26
  11. Primary completion date: Sep 1, 2021 to Oct 1, 2021 Site details revised at 1 of 25 sitesv13 Show 1 more changeShow less
    • Site details revised at 1 of 25 sites
  12. Site contacts updated at 4 of 25 sitesv12
  13. Enrollment target: 45 to 90 Primary completion date: Jan 2022 to Sep 1, 2021 · Interventions: ADP-A2M4 (Genetic) to afamitresgene autoleucel (previously ADP-A2M4) (Genetic) · Site details revised at 17 of 25 sites · 1 morev11 Show 4 more changesShow less
    • Primary completion date: Jan 2022 to Sep 1, 2021
    • Interventions: ADP-A2M4 (Genetic) to afamitresgene autoleucel (previously ADP-A2M4) (Genetic)
    • Site details revised at 17 of 25 sites
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  14. Primary completion date: Jan 1, 2022 to Jan 2022 Study sites revised (25)v10 Show 1 more changeShow less
    • Study sites revised (25)

    See this version in full on ClinicalTrials.gov ↗

  15. Enrollment target: 60 to 45 Study sites: 23 to 25 · Eligibility criteria revisedv9 Show 2 more changesShow less
    • Study sites: 23 to 25
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  16. Site details revised at 5 of 23 sitesv8
  17. Study sites revised (23)v7 See this version in full on ClinicalTrials.gov ↗
  18. Study sites: 24 to 23v6
  19. Study sites: 27 to 24v5
  20. Study sites: 26 to 27v4
  21. Start date changed from estimate of Aug 1, 2019 to Jul 24, 2019v3
  22. Trial status: Not Yet Recruiting to Recruiting Site details revised at 26 of 26 sitesv2 Show 1 more changeShow less
    • Site details revised at 26 of 26 sites
  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.
USWM CT, LLC
8 trials monitored
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Sarcoma
951 trials monitored
See 56 trials at risk
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
Trial Details
NCT Number NCT04044768
Lead Sponsor USWM CT, LLC
Conditions Synovial Sarcoma, Myxoid Liposarcoma
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov