Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

• Research type

  Research Study

• Full title

  A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants with Refractory Progressive Forms of Multiple Sclerosis

• IRAS ID

  1011413

• Contact name

  Nirav Patel

• Contact email

  nirav.patel@autolus.com

• Sponsor organisation

  Autolus Limited UK

• Eudract number

  2024-519552-93

• 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 multiple sclerosis (MS). The study is planned to take place in hospitals in Europe and the UK and will involve up to approximately 18 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 MS, the body’s immune system (B cells) mistakenly attacks healthy cells. This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to MS, including those in your brain and spinal cord. Obe-cel could work well to reduce worsening (progressive) MS when available treatments have not worked (refractory). 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 MS.
  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 autoantibody 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

  London - West London & GTAC Research Ethics Committee

• REC reference

  25/LO/0215

• Date of REC Opinion

  2 May 2025

• REC opinion

  Further Information Favourable Opinion