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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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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