RecruitingPhase 2

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

United States126 participantsStarted 2025-03-13

Plain-language summary

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 participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. 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
✕. Inadequate organ function

What they're measuring

Event-free survival (EFS)

Timeframe: From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization

Trial details

NCT IDNCT06868290

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-07

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More ANCA Associated Vasculitis (AAV) trials