Obe-cel in severe, refractory SLE

• Research type

  Research Study

• Full title

  A Single-Arm, Open-Label, Phase 1 Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Severe, Refractory Systemic Lupus Erythematosus

• IRAS ID

  1008957

• Contact name

  Sreepalreddy Vemula

• Contact email

  s.vemula@autolus.com

• Sponsor organisation

  Autolus Limited

• Research summary

  This is a study to test a new product called AUTO1 (also known as Obecabtagene Autoleucel or obe-cel). In this study, we want to find out if AUTO1 can also help treat patient’s with Systemic Lupus Erythematous (SLE). The study is planned to take place in hospitals in Europe and the UK and will involve up to approximately 12 research participants.
  AUTO1 is a CAR T Cell Immunotherapy that to date has been used to treat participants with blood cancer in several research studies. In blood cancer patients AUTO1 works by recognising an antigen (a molecule called CD19) present in blood cancer cells, which allows T cells (a type of white blood cell) to destroy them.
  People with SLE have autoantibody producing B cells (B-cells are a type of white blood cell called lymphocytes) which express CD19. It is hoped that AUTO1 will be able to reduce the number of autoantibody producing B cells and ‘reset’ the participant’s immune system to reduce their lupus symptoms. As previous studies have shown that CAR T products can cause some side-effects, we want to find out if AUTO1 is safe and whether it can treat the participant’s SLE.
  Cells will be collected through a machine which separates out white blood cells and returns the rest of the blood to the participant. The participants own T-cells are taken to a specialised laboratory. Here, a new gene is inserted into the T-cells. This gene instructs the T-cells to make a new protein called a "chimeric antigen receptor" (CAR). This CAR (AUTO1) should multiply in the participants body (like normal T cells) and should recognise and target the autoantiboy producing B cells. The AUTO1 CAR T-cells are given back to the participant via an intravenous drip. Participants will be followed up for 24 months after AUTO1 to check how safe and effective AUTO1 is. At the end of the study, the participant will be invited to take part & consent in a separate long-term safety follow up study for up to 15 years from their AUTO1 infusion.

• REC name

  North East - York Research Ethics Committee

• REC reference

  23/NE/0214

• Date of REC Opinion

  5 Jan 2024

• REC opinion

  Further Information Favourable Opinion