NCT06868290 · Novartis Pharmaceuticals
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
View original scientific description
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)
Interventions
BIOLOGICAL
Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel
OTHER
Active Comparator
Active comparator option as per protocol
DRUG
Glucocorticoids
Concomitant glucocorticoids as per protocol
Primary outcome measures
Event-free survival (EFS)
Time frame: From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
Event-free survival (EFS) defined as the time from Randomization to the first occurrence of as per protocol defined events.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- Aurora, Colorado
- Jacksonville, Florida
- Chicago, Illinois
- Boston, Massachusetts
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- Rochester, Minnesota
- Portland, Oregon
- Dallas, Texas
- Houston, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations