A Phase 2 interventional study of Rapcabtagene autoleucel and Active Comparator in ANCA Associated Vasculitis (AAV), sponsored by Novartis Pharmaceuticals. Active, not recruiting at 39 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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)
This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts:
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.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's planned enrollment of 126 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key inclusion criteria:
Key exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single infusion of rapcabtagene autoleucel (YTB323) and concomitant glucocorticoids as per protocol
Biological: Rapcabtagene autoleucel · Drug: Glucocorticoids
Comparator and concomitant glucocorticoids as per protocol
Other: Active Comparator · Drug: Glucocorticoids
Single infusion of rapcabtagene autoleucel
Active comparator option as per protocol
Concomitant glucocorticoids as per protocol
Event-free survival (EFS)
Event-free survival (EFS) defined as the time from Randomization to the first occurrence of as per protocol defined events.
Time frame: From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
Percentage of patients achieving complete remission
Complete remission is defined by Birmingham Vasculitis Activity Score version 3 (BVASv3)
Time frame: Up to Week 13
Adjusted annual cumulative GC dose between Randomization and analysis cutoff date
The adjusted annual cumulative glucocorticoid dose refers to the total amount of glucocorticoids administered to a patient over the course of a year, adjusted for any changes in dosage, and measured up to the defined week of treatment as per protocol.
Time frame: From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
ANCA seronegativity and sustaining ANCA seronegativity until the analysis cutoff date
ANCA seronegativity means that the patient tests negative for ANCA antibodies.
Time frame: From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
Change from baseline in estimated glomerular filtration rate (eGFR) at Week 39
Change from baseline in estimated glomerular filtration rate (eGFR) at Week 39.
Time frame: Up to Week 39
Change from baseline in symptoms of GPA/ MPA using the AAV-PRO at Week 39
Change from baseline in symptoms of GPA/ MPA using the AAV-PRO at Week 39.
Time frame: Up to Week 39
Change from baseline in Patient- Reported Outcome Measurement Information System (PROMIS)- Fatigue 7a at Week 91.
Change from baseline in PROMIS- Fatigue 7a at Week 91.
Time frame: Up to Week 91
Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rapcabtagene autoleucel
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →