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MB-CART19.1 in Refractory SLE

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Aug 2025 to Sep 30, 2027 Completion date: Aug 2027 to Sep 30, 2027v4 Show 1 more changeShow less
    • Completion date: Aug 2027 to Sep 30, 2027
  3. Site details revised at 1 of 3 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2024 to Aug 12, 2024 · Primary completion date: Mar 2025 to Aug 2025 · Completion date: Mar 2027 to Aug 2027 · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Mar 2024 to Aug 12, 2024
    • Primary completion date: Mar 2025 to Aug 2025
    • Completion date: Mar 2027 to Aug 2027
    • Site details revised at 3 of 3 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels. In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.
Trial Details
NCT Number NCT06189157
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions SLE - Systemic Lupus Erythematosus
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov