A Phase 1 Multicenter Open-Label Study Of CC-97540 (BMS-986353) CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells in Participants with Severe Refractory Autoimmune Diseases: Systemic Lupus Erythematosus Idiopathic Inflammatory Myopathy or Systemic Sclerosis
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Refractory Systemic Lupus Erythematosus
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Age: Between 18 Year(s) - 89 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Diagnosis of SLE
- SLE disease activity
- Active disease at screening
- Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin
- Inadequate response is defined as lack of response, insufficient response or lack of sustained response to appropriate doses. Intolerance is not considered insufficient response
- Methotrexate and azathioprine use will count as 1 for the purposes of the number of failed treatments
- Participant is = 18 years of age
You may not be eligible for this study if the following are true:
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- Diagnosis of drug-induced SLE rather than idiopathic SLE
- Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren’s syndrome are not excluded.
- SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded
- Presence or history of catastrophic antiphospholipid syndrome
- Participant has the presence of any of the following active, clinically significant central nervous system (CNS) pathology: seizure disorder, aphasia, severe brain injuries, dementia, delirium, Parkinson's disease, psychosis, cognitive dysfunction, movement disorder, cerebrovascular disease, cerebellar disease or decreased level of consciousness. Participants with history of moderate to severe neuropsychiatric lupus and/or vasculitis are excluded
- Prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for = 2 years. The following are allowed
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis clinical staging system) or prostate cancer that is curative
- Active hepatitis B, active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and/or type 2 (HTLV-1 and/or HTLV-2), or active or latent tuberculosis infection
- Uncontrolled or active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis, or within 72 hours before LD chemotherapy, or 5 days before CC-97540 administration
- History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure, myocardial infarction, unstable angina, angioplasty or stenting, or other clinically significant cardiac disease.li>
- Pregnant or nursing (lactating) women
- Use of any live vaccines against infectious disease within 8 weeks before CC-97540 administration
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.