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A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints revised (2) Eligibility criteria shortened, about 6 words · Secondary endpoints revised (9) · Study description shortened, about 2 wordsv23 Show 3 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv22
  3. Primary and study completion dates: May 2025 to Jun 30, 2029 Site details revised at 4 of 34 sitesv21 Show 1 more changeShow less
    • Site details revised at 4 of 34 sites
  4. Start date: Mar 4, 2020 to Jun 3, 2020 Site details revised at 4 of 34 sitesv20 Show 1 more changeShow less
    • Site details revised at 4 of 34 sites
  5. Primary endpoints revised (2)v19 See this version in full on ClinicalTrials.gov ↗
Show 17 earlier versionsHide 17 earlier versions
  1. Primary completion date: Jun 2023 to May 2025 Primary endpoints revised (2) · Completion date: Apr 2025 to May 2025 · Secondary endpoints revised (9)v18 Show 3 more changesShow less
    • Primary endpoints revised (2)
    • Completion date: Apr 2025 to May 2025
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 215 to confirmed 153 · Site details revised at 34 of 34 sitesv17 Show 2 more changesShow less
    • Enrollment target: estimated 215 to confirmed 153
    • Site details revised at 34 of 34 sites
  3. Primary endpoints revised (2) Enrollment target: 185 to 215 · Primary completion date: Mar 2023 to Jun 2023 · Completion date: Apr 2024 to Apr 2025 · 3 morev16 Show 6 more changesShow less
    • Enrollment target: 185 to 215
    • Primary completion date: Mar 2023 to Jun 2023
    • Completion date: Apr 2024 to Apr 2025
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 7 to 9
    • Site contacts updated at 2 of 34 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 35 to 34v15
  5. Study sites: 37 to 35v14
  6. Site contacts updated at 35 of 37 sitesv13
  7. Study sites: 34 to 37v12
  8. Study sites: 32 to 34v11
  9. Site details revised at 3 of 32 sitesv10
  10. Enrollment target: 145 to 185 Study sites: 31 to 32 · Eligibility criteria expanded, about 39 wordsv9 Show 2 more changesShow less
    • Study sites: 31 to 32
    • Eligibility criteria expanded, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  11. Site details revised at 1 of 31 sitesv8
  12. Study sites: 30 to 31v7
  13. Study sites revised (30)v6 See this version in full on ClinicalTrials.gov ↗
  14. Site details revised at 1 of 30 sitesv5
  15. Site details revised at 1 of 30 sitesv4
  16. Study sites revised (30)v3 See this version in full on ClinicalTrials.gov ↗
  17. Study sites: 31 to 30v2
  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 is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (ALL).
Trial Details
NCT Number NCT04404660
Lead Sponsor Autolus Limited
Conditions Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov