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A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 11 → 14 locations
  2. Minor Study sites: 9 to 11
  3. Notable Primary endpoints: details revised at 1 of 3 entries Study sites: 8 to 9 · Eligibility criteria expanded, about 11 words · Study description revised · 1 more Show 4 more changesShow less
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 11 words
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  4. Notable Primary endpoints: 2 to 3 Eligibility criteria shortened, about 333 words · Secondary endpoints: 17 to 10 · Study description shortened, about 99 wordsv5 Show 3 more changesShow less
    • Eligibility criteria shortened, about 333 words
    • Secondary endpoints: 17 to 10
    • Study description shortened, about 99 words

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Primary endpoints: 3 to 2 Enrollment target: 24 to 30 · Study sites: 6 to 8 · Eligibility criteria expanded, about 94 words · 3 morev4 Show 6 more changesShow less
    • Enrollment target: 24 to 30
    • Study sites: 6 to 8
    • Eligibility criteria expanded, about 94 words
    • Secondary endpoints: 12 to 17
    • Study title revised
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study sites: 1 to 6 Eligibility criteria expanded, about 89 words · Secondary endpoints revised (12) · Study description revisedv3 Show 3 more changesShow less
    • Eligibility criteria expanded, about 89 words
    • Secondary endpoints revised (12)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL).
Trial Details
NCT Number NCT06173518
Lead Sponsor Autolus Limited
Conditions Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov