The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus (SLE), idiopathic inflammatory myopathies (IIM), systemic sclerosis (SSc), rheumatoid arthritis (RA), and Sjögren's disease (SjD).
SLE participants: Must have diagnosis of SLE defined as fulfilling the 2019 ACR/EULAR classification criteria of SLE.
IIM participants: Must have diagnosis of IIM defined as fulfilling the 2017 ACR/EULAR classification criteria for probable or definite IIM.
SSc participants: Must have diagnosis of SSc defined as fulfilling 2013 ACR/EULAR classification criteria for SSc.
RA participants: Must have diagnosis of RA, defined as fulfilling 2010 ACR/EULAR criteria for RA.
Participants must not have other systemic immune disorders. Other protocol-defined Inclusion/Exclusion criteria apply.
Single group
BMS-986553
DrugSpecified dose on specified days
Number of participants with treatment emergent adverse events (TEAEs)
Number of participants with serious adverse events (SAEs)
Number of participants with adverse events of special interest (AESIs)
Number of participants with clinically significant laboratory abnormalities
Maximum observed blood concentration (Cmax) of BMS-986553
Time of maximum observed blood concentration (Tmax) of BMS-986553
Area under the curve (AUC) of BMS-986553
Percentage of participants with interstitial lung disease (ILD) with no worsening of pulmonary function
Worsening is defined as decline of ≥ 10% in absolute forced vital capacity (FVC) from baseline.
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