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Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

Study acronym: CARLYSLE
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 11% 18 → 16 participants
See other at-risk trials from Autolus Limited

Record History

  1. Enrollment closed, study ongoing Enrollment reduced: 18 → 16 participants · Site details revised at 6 of 6 sitesv6 Show 2 more changesShow less
    • Enrollment reduced: 18 → 16 participants
    • Site details revised at 6 of 6 sites
  2. Primary completion date: Dec 2025 to Sep 2027 Completion date: Dec 2026 to Sep 2027v5 Show 1 more changeShow less
    • Completion date: Dec 2026 to Sep 2027
  3. Enrollment target: 12 to 18 Study sites: 3 to 6 · Eligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 6 of 11 entries · 3 morev4 Show 6 more changesShow less
    • Study sites: 3 to 6
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 6 of 11 entries
    • Primary endpoints revised (2)
    • Study description expanded, about 2 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Nov 2024 to Dec 2025 Completion date: Oct 2025 to Dec 2026v3 Show 1 more changeShow less
    • Completion date: Oct 2025 to Dec 2026
  5. Study sites: 1 to 3 Eligibility criteria expanded, about 22 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Autolus Limited
7 trials monitored
See 1 trial at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.
Trial Details
NCT Number NCT06333483
Lead Sponsor Autolus Limited
Conditions Systemic Lupus Erythematosus
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov