The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
179
single infusion of rapcabtagene autoleucel
Evaluate the efficacy of rapcabtagene autoleucel
Defined as: Meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) or Achieving complete renal response (CRR)
Time frame: Week 24, Week 52
Percentage of participants achieving complete renal response (CRR)
CRR is a composite endpoint
Time frame: Week 52
Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved
Lupus Low Disease Activity State (LLDAS)
Time frame: Week 12 to Week 52
PPercentage of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares)
British Isles Lupus Activity Group (BILAG2004) records disease activity occurring over the past 4 weeks.
Time frame: Week 12 to Week 52
Annualized cumulative corticosteroids dose
The total dose of corticosteroids used up to Week 52 per patient.
Time frame: Week 52
Percentage of participants who are negative for serological status
The percentage of participants with negative serological status
Time frame: Week 52
FACIT-Fatigue score change from baseline
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item patient- reported outcomes measure
Time frame: Baseline to Week 52
Maintained DORIS
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University Of Alabama
Birmingham, Alabama, United States
RECRUITINGLoma Linda University
San Bernardino, California, United States
RECRUITINGUCSF
San Francisco, California, United States
RECRUITINGUCSF
San Francisco, California, United States
RECRUITINGSutter Health Network
San Pablo, California, United States
RECRUITINGAnn and Robert H Lurie Childs Hosp
Chicago, Illinois, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGUniversity Of Iowa
Iowa City, Iowa, United States
RECRUITINGUniversity of Kentucky
Lexington, Kentucky, United States
RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
RECRUITING...and 83 more locations
Definition Of Remission In Systemic Lupus Erythematosus (DORIS)
Time frame: Week 52 to Week 76