NCT06868290Active, not recruitingPhase 2
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
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)
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 7 Mar 2025
- Start date
- 13 Mar 2025
- Primary completion date
- 7 Jun 2029
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT06868290
- EU CT number
- 2024-515854-26-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 126
- From 13 Mar 2025 to the primary completion date, 7 Jun 2029
- 37 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 tolerate CD19 CAR-T cell therapy
Other
- Inadequate organ function
Who the study is looking for
- 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
- Positive test for ANCA-autoantibodies
- GPA and MPA participants with severe active disease
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ishikawa | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Shinjuku Ku | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Michigan Med University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Uni of Chi Medi Ctr Hema and Onco Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke Clinical Research Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| LDS Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.