Obe-cel in Severe, Refractory Systemic Lupus Erythematosus with Active Lupus Nephritis

• Research type

  Research Study

• Full title

  A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (OBE-CEL) in Participants with Severe, Refractory Systemic Lupus Erythematosus with Active Lupus Nephritis

• IRAS ID

  1011415

• Contact name

  Didem Crosby

• Contact email

  d.crosby@autolus.com

• Sponsor organisation

  Autolus Limited UK

• Eudract number

  2024-519941-32

• Research summary

  The purpose of this Phase II open-label study is to assess the safety and effect of a single dose of obecabtagene autoleucel (obe-cel), autologous CAR T cells, in participants with systemic lupus erythematosus with active LN following lymphodepletion. The primary endpoint is the proportion of participants with a complete renal response at Month 6.
  Study details include:
  Number of participants to be treated: 30
  Study duration for an individual participant: 24 months
  Treatment duration: single infusion
  Number of participant study visits: approximately 30
  Visit frequency: variable, with frequent visits for the first 2 to 3 months (screening, leukapheresis, lymphodepletion, treatment with obe-cel at Day 1, then 8 further visits to Day 28) followed by 11 monthly visits to Month 12, four 3-monthly visits to Month 24, and additional 6-monthly visits until last participant last visit.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  25/SC/0086

• Date of REC Opinion

  19 May 2025

• REC opinion

  Further Information Favourable Opinion