US Zamto-cel Autoimmune Diseases

Korábbi kezelés

• Prior gene therapy treatment
• Drug-induced SLE.
  • Systemic Lupus Erythematosus - Lupus Nephritis Key Inclusion/Exclusion Criteria
• History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc

Más betegség

• Active malignancy within past 5 years
• Significant active fungal or bacterial infection
• History or presence of CNS lupus or other CNS disease
• "Active" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment.

Laborértékek

• eGFR < 45 mL/min/1.73 m\^2
• Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).
  • Systemic Lupus Erythematosus-Non-renal Key Inclusion/Exclusion Criteria
• •Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator.

Egyéb

• Subjects with neuropsychiatric SLE.
• Systemic Sclerosis/Diffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion/ Exclusion 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)

A regiszterben nem jelölt feltételek

• General Key Inclusion/Exclusion Criteria Across All Cohorts