A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
- Conditions
- Refractory Autoimmune Diseases
- Interventions
- Registration Number
- NCT07115745
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Systemic lupus erythematosus (SLE) population:.
i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody.
iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.
iv) Participants must have active disease at screening.
- Inflammatory myopathy (IIM) population:.
i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.
iv) Evidence of active disease.
- Systemic sclerosis (SSc) population:.
i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.
ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease.
- Rheumatoid arthritis (RA) population:.
i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy.
- All participants:.
i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening.
vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.
-
SLE population:.
i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
-
IIM population:.
i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
-
SSc population:.
i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.
ii) Rapidly deteriorating SSc, or history of severe kidney disease.
-
RA population:.
i) People who have additional autoimmune diseases along with RA.
-
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986515 Administration BMS-986515 - BMS-986515 Administration Fludarabine - BMS-986515 Administration Cyclophosphamide - BMS-986515 Administration Tocilizumab -
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) Up to 24 months post BMS-986515 infusion All participants
Number of participants with serious AEs (SAEs) Up to 24 months post BMS-986515 infusion All participants
Number of participants with AEs of special interest (AESIs) Up to 24 months post BMS-986515 infusion All participants
Number of participants with laboratory abnormalities Up to 24 months post BMS-986515 infusion All participants
Number of participants with Dose-Limiting Toxicities (DLTs) Up to 24 months post BMS-986515 infusion All participants
Number of participants with DLTs that occur during the DLT evaluation period 28 days post-BMS-986515 infusion All participants
- Secondary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Up to 2 years All participants
Area under the concentration-time curve (AUC) Up to 2 years All participants
Time of maximum observed concentration (Tmax) Up to 2 years All participants
Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24 Up to 2 years All participants
Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24 Up to Week 24 Systemic lupus erythematosus (SLE) participants
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24 Up to Week 24 SLE participants
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24 Up to Week 24 SLE participants
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24 Up to Week 24 SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24 Up to Week 24 Inflammatory myopathy (IIM) participants
Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline Up to Week 24 IIM participants
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline Up to Week 24 Dermatomyositis (DM) participants only
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 Up to Week 24 SSc participants
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24 Up to Week 24 SSc participants
Number of participants with low disease activity at Week 24 from baseline Up to Week 24 RA participants
Trial Locations
- Locations (32)
Local Institution - 0036
🇺🇸New York, New York, United States
Local Institution - 0037
🇺🇸Durham, North Carolina, United States
Local Institution - 0033
🇺🇸Seattle, Washington, United States
Local Institution - 0007
🇦🇺Camperdown, New South Wales, Australia
Local Institution - 0008
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0013
🇦🇺Clayton, Victoria, Australia
Local Institution - 0040
🇧🇷Salvador, Bahia, Brazil
Local Institution - 0039
🇧🇷Porto Alegre, Brazil
Local Institution - 0038
🇧🇷Sao Paulo, Brazil
Local Institution - 0004
🇨🇿Praha, Praha 5, Czechia
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