BridgeMD
New treatment option for ANCA Associated Vasculitis (AAV)
Official title Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
ClinicalTrials.gov ID: NCT06868290
What this study is testing
What is Rapcabtagene autoleucel?
Rapcabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anca associated vasculitis (aav).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Positive test for ANCA-autoantibodies
- GPA and MPA participants with severe active disease Key
You likely can't join if
- Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and...
- 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
- Inadequate organ function
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.