A phase 1/2 study to evaluate safety and efficacy of CABA-201 in patients with inflammatory Myopathy

• Research type

  Research Study

• Full title

  A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy

• IRAS ID

  1008852

• Contact name

  Christina Shepherd

• Contact email

  cshepherd@advancedclinical.com

• Sponsor organisation

  Cabaletta Bio, Inc.

• Clinicaltrials.gov Identifier

  NCT06154252

• Research summary

  This study is testing CABA-201 in adult patients with Idiopathic Inflammatory Myopathy, including dermatomyositis, anti-synthetase syndrome, or immune-mediated necrotizing myopathy, who are not seeing improvement from other treatments. CABA-201 is a chimeric antigen receptor T cell therapy (CART) that aims to find and remove B cells in the patient's body , including those that are thought to cause their disease. Prior to CABA-201 infusion, patients will receive a pre conditioning treatment of fludarabine and cyclophosphamide to help the CABA-201 infusion work better. Patients will be expected to remain on study for up to 3 years, including screening, pre-treatment, CABA-201 infusion and follow up, with an additional long term follow up period of 15 years post CABA-201 infusion.

• REC name

  North East - York Research Ethics Committee

• REC reference

  24/NE/0081

• Date of REC Opinion

  11 Jun 2024

• REC opinion

  Further Information Favourable Opinion