US Zamto-cel Autoimmune Diseases

General Key Inclusion/Exclusion Criteria Across All Cohorts

Inclusion Criteria:

•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc/ dcSSc)

Exclusion Criteria:

• Prior gene therapy treatment

• Active malignancy within past 5 years

• Significant active fungal or bacterial infection

• History or presence of CNS lupus or other CNS disease

• eGFR < 45 mL/min/1.73 m^2

• Total bilirubin outside the normal range (unless congenital hyperbilirubinemia suchas Gilbert syndrome has been confirmed).

Systemic Lupus Erythematosus-Non-renal Key Inclusion/Exclusion Criteria

Inclusion Criteria:

• Positive for at least 1 of the following autoantibodies at Screening: anti- doublestranded DNA or anti-Smith

• Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation)organ scores

• Inadequate response to glucocorticoids and to at least 2 of the followingtreatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid orits derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, orobinutuzumab

Exclusion Criteria:

• Subjects with neuropsychiatric SLE.

• Drug-induced SLE.

Systemic Lupus Erythematosus - Lupus Nephritis Key Inclusion/Exclusion Criteria

Inclusion Criteria:

• Positive for at least 1 of the following autoantibodies at Screening: anti- doublestranded DNA or anti-Smith

• Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6months, with severe active phase of the disease.

• Progressing despite maintenance on maximally tolerated doses of renin- angiotensinsystem (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors andARBs

• Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of thefollowing treatments, used for at least 3 months each: cyclophosphamide,mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab,obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)

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.

Systemic Sclerosis/Diffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion/ Exclusion Criteria

Inclusion Criteria:

• Active disease defined as:

• Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or moreof 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 byhigh-resolution computed tomography

• Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressivetherapies)

Exclusion Criteria:

• "Active" gastric antral vascular ectasia, as evidenced by bleeding (ie, onesophagogastroduodenoscopy) in the past 6 months or as per Investigator'sassessment.

• History of SSc renal crisis within 1 year prior to Screening; presence of kidneyimpairment due to conditions other than SSc