Home › Trials › NCT06868290

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

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)

Phase 2 Interventional Novartis · NCT06868290

This study is testing a new CAR-T therapy to see if it can help people with severe forms of vasculitis feel better compared to standard treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment126 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsCAR-T
Locations31 sites (Aurora, Colorado and 30 other locations)
Trial IDNCT06868290 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of GPA or MPA and positive ANCA-autoantibodies.

Not a fit: Patients with other systemic autoimmune diseases or those unable to tolerate CAR-T therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients suffering from severe ANCA-associated vasculitis.

How similar studies have performed: Other studies have shown promise with CAR-T therapies in autoimmune conditions, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Aurora, Colorado and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ANCA Associated VasculitisChimeric Antigen Receptor-Trapcabtagene autoleucelanti-neutrophil cytoplasmic antibodyANCA-associated vasculitis/vasculitidesGranulomatosis with PolyangiitisMicroscopic Polyangiitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.