Evaluating a new CAR-T therapy for severe ANCA-associated vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study aims to assess the efficacy and safety of rapcabtagene autoleucel in patients with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA). Participants will be randomized to receive either the experimental CAR-T therapy or a comparator treatment. The study includes a lead-in cohort for initial treatment followed by a long-term follow-up period lasting up to 15 years for those receiving the CAR-T infusion. The goal is to determine how well this therapy works compared to standard treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• University Of Colorado
  Aurora, Colorado, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic Rochester
  Rochester, Minnesota, United States Recruiting
• Oregon Health Sciences University
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.