A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)

简要总结

主要结局

次要结局

• Patient Global Impression of Change (PGI-C) Pain and PGI-C Fatigue
• Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
• Participants with drug-free DORIS remission
• CRR for participants with baseline LN
• Modified CRR for participants with baseline LN
• Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6
• Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6
• Number and Severity of participants with flares as assessed by SLEDAI flare index
• Change from baseline in proteinuria and estimated glomerular filtration rate (eGFR)
• Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage
• Number and frequency of participants achieving maintenance of drug-free DORIS remission, LLDAS, and SRI-4.
• Time from first response to loss of response for drug-free DORIS remission, Time from first response to loss of response for LLDAS, and Time from first response to loss of response for SRI-4
• Time from baseline to first drug-free DORIS remission, LLDAS, and SRI-4
• Duration of drug-free status
• Percentage of participants achieving DORIS remission regardless of drug-free status
• Cumulative glucocorticoid dose post-infusion used for SLE treatment
• Change of serum autoantibodies and complement factors from baseline
• Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue, SF 36 v2 Acute, EQ-5D-5L, Patient Global Impression of Severity (PGI-S) Pain, and PGI-S Fatigue