The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants with treatment-emergent adverse events (TEAEs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with serious AEs (SAEs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with AEs of special interest (AESIs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with laboratory abnormalities
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with Dose-Limiting Toxicities (DLTs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with DLTs that occur during the DLT evaluation period
All participants
Time frame: 28 days post-BMS-986515 infusion
Maximum observed concentration (Cmax)
All participants
Time frame: Up to 2 years
Area under the concentration-time curve (AUC)
All participants
Time frame: Up to 2 years
Time of maximum observed concentration (Tmax)
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CONTACT
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CONTACT
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Specified dose on specified days
Local Institution - 0041
Boston, Massachusetts, United States
NOT_YET_RECRUITINGLocal Institution - 0037
Durham, North Carolina, United States
NOT_YET_RECRUITINGLocal Institution - 0033
Seattle, Washington, United States
NOT_YET_RECRUITINGLocal Institution - 0007
Camperdown, New South Wales, Australia
NOT_YET_RECRUITINGLocal Institution - 0008
Brisbane, Queensland, Australia
NOT_YET_RECRUITINGLocal Institution - 0013
Clayton, Victoria, Australia
NOT_YET_RECRUITINGLocal Institution - 0040
Salvador, Estado de Bahia, Brazil
NOT_YET_RECRUITINGLocal Institution - 0039
Porto Alegre, Brazil
NOT_YET_RECRUITINGLocal Institution - 0038
São Paulo, Brazil
NOT_YET_RECRUITINGLocal Institution - 0004
Prague, Praha 5, Czechia
NOT_YET_RECRUITING...and 19 more locations
All participants
Time frame: Up to 2 years
Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24
All participants
Time frame: Up to 2 years
Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24
Systemic lupus erythematosus (SLE) participants
Time frame: Up to Week 24
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24
SLE participants
Time frame: Up to Week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24
SLE participants
Time frame: Up to Week 24
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24
SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants
Time frame: Up to Week 24
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24
Inflammatory myopathy (IIM) participants
Time frame: Up to Week 24
Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline
IIM participants
Time frame: Up to Week 24
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline
Dermatomyositis (DM) participants only
Time frame: Up to Week 24
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
SSc participants
Time frame: Up to Week 24
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24
SSc participants
Time frame: Up to Week 24
Number of participants with low disease activity at Week 24 from baseline
RA participants
Time frame: Up to Week 24