Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

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