RECRUITINGPhase 2INTERVENTIONAL
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
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)
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)
Who May Be Eligible (Plain English)
Key Who May Qualify:
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 Who Should NOT Join This Trial:
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 conditions (where your immune system attacks your own body)s 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. Inyour organs (liver, kidneys, etc.) are working well enough based on blood tests
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel
OTHER
Active Comparator
Active comparator option as per protocol
DRUG
Glucocorticoids
Concomitant glucocorticoids as per protocol
Locations (20)
University Of Colorado
Aurora, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Oregon Health Sciences University
Portland, Oregon, United States
Houston Methodist Hospital
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Novartis Investigative Site
Barretos, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, Brazil
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan