BMS-986515 CAR T Cells for Severe Refractory Autoimmune Diseases

Cyclophosphamide

BMS-986515

Fludarabine

Tocilizumab

Number of participants with serious AEs (SAEs)

Number of participants with treatment-emergent adverse events (TEAEs)

Number of participants with AEs of special interest (AESIs)

Number of participants with laboratory abnormalities

Number of participants with Dose-Limiting Toxicities (DLTs)

Number of participants with DLTs that occur during the DLT evaluation period

Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24

Time of maximum observed concentration (Tmax)

Area under the concentration-time curve (AUC)

Maximum observed concentration (Cmax)

Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24

Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24

Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24

Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24

Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24

Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline

Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline

Number of participants who achieve an minimal clinically important differences in SSc (MCID) from baseline of the modified Rodnan Skin Score (mRSS) at Week 24

Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24

Number of participants with low disease activity at Week 24 from baseline