At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Rapcabtagene autoleucel (biological), Active Comparator (other), Glucocorticoids (drug)
- How long the study runs
- Study runs about 62 months (dates as stated)
- About the drug or intervention
- Rapcabtagene autoleucel — biological: Single infusion of rapcabtagene autoleucel · Active Comparator — other: Active comparator option as per protocol · Glucocorticoids — drug: Concomitant glucocorticoids as per protocol
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a phase 2 study testing a treatment called rapcabtagene autoleucel in people aged 18 to 75 with severe active GPA (granulomatosis with polyangiitis) or MPA (microscopic polyangiitis). These are types of ANCA associated vasculitis (AAV), a condition where the immune system attacks blood vessels. The study is funded by Novartis Pharmaceuticals.
Who can take part
- Adults aged 18 to 75 with a diagnosis of GPA or MPA based on the ACR/EULAR 2022 classification criteria
- A positive test for ANCA auto-antibodies (proteins made by the immune system)
- Severe active disease
Who may not be able to
- Any condition that could stop you safely stopping your current medicines, or that would make CAR-T cell therapy (a treatment using your own immune cells) unsuitable for you
- Allergies or reasons you cannot have any of the products given in the study
- Other autoimmune diseases affecting the whole body that need treatment
- Medical conditions not related to GPA or MPA that would make it hard to cope with CAR-T cell therapy
- Organs (such as the liver or kidneys) not working well enough
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 126
- Started
- 2025-03-13
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for anca associated vasculitis (aav)
- • Phase2 - 126 participants
- • The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with anca associated vasculitis (aav)
Where?
- • Cambridge - Novartis Investigative Site
- • Glasgow - Novartis Investigative Site
- • London - Novartis Investigative Site
- • Manchester - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
More detail
This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts: * A lead-in cohort enrolling participants to receive rapcabtagene autoleucel * A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator. After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Positive test for ANCA-autoantibodies
- ✓GPA and MPA participants with severe active disease
Who cannot take part
- ✗Any condition that could prevent a complete washout of medications or could otherwise make the participant...
- ✗Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol
- ✗Other systemic autoimmune diseases requiring therapy
- ✗Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to...
- ✗Inhealthy organ
See the full criteria
Where Is This Study? (4 UK sites)
Novartis Investigative Site
Cambridge CB2 0QQ, United Kingdom
Novartis Investigative Site
Glasgow G4 0SF, United Kingdom
Novartis Investigative Site
London W12 0HS, United Kingdom
Novartis Investigative Site
Manchester M13 9WL, United Kingdom