ANCA-Vasculitis YTB323 CAR-T Therapy Trial
Research type
Research Study
Full title
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
IRAS ID
1010670
Contact name
Léa Dusuel
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
This research study to find out if rapcabtagene autoleucel (also referred to as YTB323), an investigational new therapy, is safe and effective (can help) in people who have severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA), which are different types of small vessel vasculitis conditions. YTB323 is a chimeric antigen receptor (CAR) T cell therapy, which is a type of gene therapy/immunotherapy. CAR-T cell therapy involves collecting and using the participant’s own immune cells, specifically their T cells, to treat their disease. T cells are immune cells that help fight bacteria and viruses. After collection, the participant’s T cells are sent to the manufacturer’s (Novartis) laboratory, where they are genetically “modified” to fight and destroy another type of immune cells called B cells, which are believed to contribute to vasculitis. In a part of this study, the effect of YTB323 will be compared against Rituximab, which belongs to a class of drugs known as monoclonal antibodies and destroys B cells in the body.
About 126 participants in approximately 16 countries will participate in this study. YTB323 is a type of gene therapy/immunotherapy so, patients who have received it during the study, will be asked to join a separate long-term safety follow-up study, which includes onsite follow-up visits and phone follow-up visits for up to 15 years after receiving YTB323.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0141
Date of REC Opinion
20 Mar 2025
REC opinion
Further Information Favourable Opinion