US Zamto-cel Autoimmune Diseases

Inclusion Criteria

• •Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc/ dcSSc)
• •Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith
• •Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores
• •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, or obinutuzumab
• •Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith
• •Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease.
• •Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs
• •Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)
• •Active disease defined as:
• •Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:
• •* Increase in mRSS by ≥ 3 units or 10%
• •* Involvement of 1 new body area with increase in mRSS by ≥ 2 units
• •* Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR
• •Progressive interstitial lung disease (ILD) defined as:
• •\- Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography
• •Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)