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A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Dec 1, 2027 to Dec 1, 2026 Completion moved earlier from Jan 1, 2030 to Jan 1, 2029 · Eligibility criteria expanded, about 73 wordsv19 Show 2 more changesShow less
    • Completion moved earlier from Jan 1, 2030 to Jan 1, 2029
    • Eligibility criteria expanded, about 73 words

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Jun 17, 2026, no change to tracked fieldsv17-v18
  3. Primary completion pushed from Dec 1, 2026 to Dec 1, 2027 Enrollment increased: 32 → 100 participants · Completion pushed from Jan 1, 2029 to Jan 1, 2030 · Study sites: 9 to 8 · 1 morev16 Show 4 more changesShow less
    • Enrollment increased: 32 → 100 participants
    • Completion pushed from Jan 1, 2029 to Jan 1, 2030
    • Study sites: 9 to 8
    • Eligibility criteria expanded, about 279 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 8 to 9v15
  5. Study sites: 7 to 8 Secondary endpoints: details revised at 5 of 14 entriesv14 Show 1 more changeShow less
    • Secondary endpoints: details revised at 5 of 14 entries
Show 12 earlier versionsHide 12 earlier versions
  1. Secondary endpoints: details revised at 5 of 14 entriesv13
  2. Secondary endpoints: 8 to 14 Eligibility criteria shortened, about 3 wordsv12 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 7 sitesv11
  4. Study sites: 5 to 7v10
  5. Re-verified, no change to tracked fieldsv9
  6. Study sites: 3 to 5v8
  7. Study sites: 2 to 3v7
  8. Start date: Jan 15, 2025 to May 6, 2025v6
  9. Study sites: 1 to 2v5
  10. Start date: Jan 17, 2025 to Jan 15, 2025v4
  11. Re-verified, no change to tracked fieldsv3
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 1, 2024 to Jan 17, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2024 to Jan 17, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Trial Details
NCT Number NCT06680037
Lead Sponsor TG Therapeutics, Inc.
Conditions B-cell Mediated Autoimmune Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov