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Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)

Study acronym: LUMINA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 14 to 15v7
  2. Study sites: 12 to 14v6
  3. Study sites: 10 to 12v5
  4. Primary endpoint(s) modified Trial sites reduced: 26 → 10 locations · Eligibility criteria shortened, about 37 words · Secondary endpoints: 21 to 13 · 2 morev4 Show 5 more changesShow less
    • Trial sites reduced: 26 → 10 locations
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: 21 to 13
    • Study description shortened, about 38 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2025 to Jan 16, 2026 · Study sites: 0 to 26 · Primary completion date: Feb 2029 to Aug 2028 · 3 morev3 Show 6 more changesShow less
    • Start date changed from estimate of Sep 2025 to Jan 16, 2026
    • Study sites: 0 to 26
    • Primary completion date: Feb 2029 to Aug 2028
    • Completion date: Feb 2030 to Oct 2029
    • Secondary endpoints: details revised at 1 of 21 entries
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Start date: Jul 2025 to Sep 2025 Primary endpoint revised · Primary completion date: Dec 2028 to Feb 2029 · Completion date: Dec 2029 to Feb 2030 · 3 morev2 Show 6 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Dec 2028 to Feb 2029
    • Completion date: Dec 2029 to Feb 2030
    • Eligibility criteria shortened, about 395 words
    • Secondary endpoints: 71 to 21
    • Study description expanded, about 140 words

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).
Trial Details
NCT Number NCT07053800
Lead Sponsor Autolus Limited
Collaborators: PPD Development, LP
Conditions Lupus Nephritis
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov