Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
NCT ID: NCT06868290
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
126 participants
INTERVENTIONAL
2025-03-13
2030-05-24
Brief Summary
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Detailed Description
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* A lead-in cohort enrolling participants to receive rapcabtagene autoleucel
* A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator.
After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel (YTB323) and concomitant glucocorticoids as per protocol
Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel
Glucocorticoids
Concomitant glucocorticoids as per protocol
Active comparator
Comparator and concomitant glucocorticoids as per protocol
Active Comparator
Active comparator option as per protocol
Glucocorticoids
Concomitant glucocorticoids as per protocol
Interventions
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Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel
Active Comparator
Active comparator option as per protocol
Glucocorticoids
Concomitant glucocorticoids as per protocol
Eligibility Criteria
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Inclusion Criteria
2. Positive test for ANCA-autoantibodies
3. GPA and MPA participants with severe active disease
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, , Brazil
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Haifa, , Israel
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Ramat Gan, , Israel
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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
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Chiba, , Japan
Novartis Investigative Site
Fukuoka, , Japan
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Kyoto, , Japan
Novartis Investigative Site
Riyadh, , Saudi Arabia
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
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Basel, , Switzerland
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Cambridge, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Chong Pedrick
Role: primary
John Hatzimouratides Jr.
Role: primary
Matthew Selle
Role: primary
Michael Rabinovich
Role: primary
Josephine Baum
Role: primary
Rosy Quinn
Role: primary
Jennifer Garrett
Role: primary
Tara Sou
Role: primary
Other Identifiers
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CYTB323I12201
Identifier Type: -
Identifier Source: org_study_id