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NCT06868290Active, not recruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
126 (estimated)
First submitted
7 Mar 2025
Start date
13 Mar 2025
Primary completion date
7 Jun 2029
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT06868290
EU CT number
2024-515854-26-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 126
  • From 13 Mar 2025 to the primary completion date, 7 Jun 2029
  • 37 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Inadequate organ function

Who the study is looking for

  • 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
  • Positive test for ANCA-autoantibodies
  • GPA and MPA participants with severe active disease

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
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BarretosBrazilUnknown status
Novartis Investigative Site
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SalvadorBrazilUnknown status
Novartis Investigative Site
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São PauloBrazilUnknown status
Novartis Investigative Site
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BaselSwitzerlandUnknown status
Novartis Investigative Site
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BernSwitzerlandUnknown status
Novartis Investigative Site
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CambridgeUnited KingdomUnknown status
Novartis Investigative Site
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GlasgowUnited KingdomUnknown status
Novartis Investigative Site
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LondonUnited KingdomUnknown status
Novartis Investigative Site
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ManchesterUnited KingdomUnknown status
Novartis Investigative Site
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HaifaIsraelUnknown status
Novartis Investigative Site
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Ramat GanIsraelUnknown status
Novartis Investigative Site
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Bunkyo KuJapanUnknown status
Novartis Investigative Site
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ChibaJapanUnknown status
Novartis Investigative Site
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FukuokaJapanUnknown status
Novartis Investigative Site
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IshikawaJapanUnknown status
Novartis Investigative Site
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KobeJapanUnknown status
Novartis Investigative Site
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KyotoJapanUnknown status
Novartis Investigative Site
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SapporoJapanUnknown status
Novartis Investigative Site
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SendaiJapanUnknown status
Novartis Investigative Site
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Shinjuku KuJapanUnknown status
Novartis Investigative Site
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SuitaJapanUnknown status
Novartis Investigative Site
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RiyadhSaudi ArabiaUnknown status
Novartis Investigative Site
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SingaporeSingaporeUnknown status
Michigan Med University of Michigan
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Ann ArborUnited StatesUnknown status
University of Colorado
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AuroraUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Uni of Chi Medi Ctr Hema and Onco
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ChicagoUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
Duke Clinical Research Institute
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DurhamUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Oregon Health Sciences University
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PortlandUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
LDS Hospital
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Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.