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

NCT06868290

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: ANCA Associated Vasculitis (AAV)

Interventions: Rapcabtagene autoleucel, Active Comparator, Glucocorticoids

Countries: United States, Brazil, Israel, Japan, Saudi Arabia, Singapore, Switzerland, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (35)
  • Aurora, Colorado, United States
  • Jacksonville, Florida, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Rochester, Minnesota, United States
  • Portland, Oregon, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Salvador, Estado de Bahia, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, Brazil
  • Haifa, Israel
  • Ramat Gan, Israel
  • Sapporo, Hokkaido, Japan
  • Kobe, Hyōgo, Japan
  • Sendai, Miyagi, Japan
  • Suita, Osaka, Japan
  • Bunkyo Ku, Tokyo, Japan
  • Shinjuku-ku, Tokyo, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Ishikawa, Japan
  • Kyoto, Japan
  • Riyadh, Saudi Arabia
  • Singapore, Singapore
  • Singapore, Singapore
  • + 5 more on CT.gov