Last Update: May 20, 2026 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) ClinicalTrials.gov Identifier: [NCT06868290](https://clinicaltrials.gov/ct2/show/NCT06868290) Novartis Reference Number:CYTB323I12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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) 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. Condition ANCA Associated Vasculitis (AAV) Phase Phase2 Overall Status Recruiting Number of Participants126 Start Date Mar 13, 2025 Completion Date May 24, 2030 Gender All Age(s) 18 Years - 75 Years (Adult, Older Adult) ## Interventions Other ### Active Comparator Active comparator option as per protocol Drug ### Glucocorticoids Concomitant glucocorticoids as per protocol Biological ### Rapcabtagene autoleucel Single infusion of rapcabtagene autoleucel ## Eligibility Criteria Key inclusion criteria: 1\. Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria 2\. Positive test for ANCA-autoantibodies 3\. GPA and MPA participants with severe active disease Key exclusion criteria: 1\. Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study 2\. Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol 3\. Other systemic autoimmune diseases requiring therapy 4\. Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy 5\. Inadequate organ function Brazil #### Novartis Investigative Site Recruiting São Paulo,01509-010,Brazil #### Novartis Investigative Site Recruiting Salvador,Estado de Bahia,41253-190,Brazil #### Novartis Investigative Site Recruiting São Paulo,São Paulo,01308-050,Brazil #### Novartis Investigative Site Recruiting Barretos,São Paulo,14784 400,Brazil Israel #### Novartis Investigative Site Recruiting Haifa,3109601,Israel #### Novartis Investigative Site Recruiting Ramat Gan,5265601,Israel Japan #### Novartis Investigative Site Recruiting Kyoto,6068507,Japan #### Novartis Investigative Site Recruiting Kobe,Hyōgo,6500047,Japan #### Novartis Investigative Site Recruiting Fukuoka,8128582,Japan #### Novartis Investigative Site Recruiting Sendai,Miyagi,9808574,Japan #### Novartis Investigative Site Recruiting Bunkyo Ku,Tokyo,1138431,Japan #### Novartis Investigative Site Recruiting Shinjuku-ku,Tokyo,1608582,Japan #### Novartis Investigative Site Recruiting Sapporo,Hokkaido,060-8648,Japan #### Novartis Investigative Site Recruiting Suita,Osaka,565-0871,Japan #### Novartis Investigative Site Recruiting Chiba,2608677,Japan #### Novartis Investigative Site Recruiting Ishikawa,9208641,Japan Saudi Arabia #### Novartis Investigative Site Recruiting Riyadh,11211,Saudi Arabia Singapore #### Novartis Investigative Site Recruiting Singapore,S308433,Singapore #### Novartis Investigative Site Recruiting Singapore,119074,Singapore Switzerland #### Novartis Investigative Site Recruiting Bern,3010,Switzerland #### Novartis Investigative Site Recruiting Basel,4031,Switzerland United Kingdom #### Novartis Investigative Site Recruiting Manchester,M13 9wl,United Kingdom #### Novartis Investigative Site Recruiting London,W12 0hs,United Kingdom #### Novartis Investigative Site Recruiting Cambridge,Cb2 0qq,United Kingdom United States #### Michigan Med University of Michigan Recruiting Ann Arbor,Michigan,48109 5271,United States ###### Abigail Mattison Email: ###### Monalisa Ghosh #### Oregon Health Sciences University Recruiting Portland,Oregon,97239,United States ###### Atul Deodhar ###### Rosy Quinn Email: #### LDS Hospital Recruiting Salt Lake City,Utah,84143,United States ###### Catherine Jennifer Bakewell ###### Tara Sou Phone: [801-408-1100](tel:801-408-1100) Email: #### University Of Colorado Recruiting Aurora,Colorado,80045,United States ###### Chong Pedrick Phone: [303-724-8948](tel:303-724-8948) Email: ###### Larry Moreland #### Baylor University Medical Center Recruiting Dallas,Texas,75246,United States ###### Tarah Satterfield Email: ###### Houston Holmes #### University of Minnesota Recruiting Minneapolis,Minnesota,55455,United States ###### Patrick Nachman ###### Michelle Snyder Email: #### Houston Methodist Hospital Recruiting Houston,Texas,77030,United States ###### Sarah Kazzaz ###### Jennifer Garrett Email: #### Mayo Clinic Jacksonville Recruiting Jacksonville,Florida,32224,United States ###### John Hatzimouratides Jr. Phone: [904-953-7648](tel:904-953-7648) Email: ###### Vikas Majithia #### Northwestern University Recruiting Chicago,Illinois,60611,United States ###### Anisha Dua ###### John Seagrist Email: #### Massachusetts General Hospital Recruiting Boston,Massachusetts,02114,United States ###### John Stone ###### Michael Rabinovich Phone: [617-726-7938](tel:617-726-7938) Email: #### Mayo Clinic Rochester Recruiting Rochester,Minnesota,55905,United States ###### Josephine Baum Phone: [507-284-2467](tel:507-284-2467) Email: ###### Ulrich Specks ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: