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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovartis Pharmaceuticals

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Rapcabtagene autoleucel
  • Active Comparator
  • Glucocorticoids

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators