Engineered immune cells take on lupus and scleroderma in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN): * Age ≥ 18 years * Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE * Presence of either double-stranded deoxyribonucleic acid (DNA) anti- double-stranded DNA (anti-dsDNA) and/or anti-Smith antibodies at screening per local laboratory. * Moderate to severe, active disease defined as at least one British Isles Lupus Assessment Group (BILAG-A) score or 2 BILAG B (excluding constitutional and/or neuropsychiatric organ system). * Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, anifrolumab, rituximab, obinutuzumab, methotrexate, azathioprine, cyclosporin, tacrolimus, or voclosporin. * For LN: Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, rituximab, obinutuzumab, azathioprine, cyclosporin, tacrolimus, or voclosporin Inclusion Criteria for LN: * Renal biopsy-proven Class III or intravenous (IV) ± V LN according to the revised International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria within 6 months prior to or during screening * Evidence of active LN at screening Inclusion Criteria for systemic sclerosis (SSc): * Age ≥ 18 years * Diffuse Systemic Sclerosis (SSc) according to ACR/EULAR 2013 classification criteria with active skin disease and/or progressive SSc-interstitial lung disease (ILD) OR limited SSc with progressive ILD. * Refractory or intolerance to 1 of the following for a minimum of 3 months and/or contraindication: mycophenolate mofetil or its derivatives, methotrexate, tocilizumab (or other IL-6 inhibitor), rituximab (or other B-cell depleting agent), nintedanib (or other antifibrotic agents), cyclophosphamide. * High-resolution computer tomography (HRCT) scan and pulmonary function test (PFT) within 3 months prior to screening. Inclusion Criteria for idiopathic inflammatory myopathy (IIM): * Age ≥ 18 years * Probable or definite IIM based on EULAR/ACR 2017 classification (excluding inclusion body myositis). * Active disease demonstrated by electromyography (EMG), magnetic resonance imaging (MRI) or muscle enzymes * Moderate to severe disease activity * Positive for myositis specific antibodies for patients with non-dermatomyostitis IIM * HRCT scan and PFT within 3 months prior to screening. * Refractory or intolerance to at least 1 month of glucocorticoids and standardized use of at least 2 immunosuppressant/modulator (eg, intravenous gamma globulins, methotrexate, mycophenolate mofetil and its derivatives, azathioprine, cyclophosphamide, calcineurin inhibitors, Janus kinase (JAK) inhibitors, rituximab or other B-cell depleting agent). Inclusion Criteria for all Cohorts: * Adequate hepatic, renal, pulmonary, and cardiac function. Key Exclusion Criteria: Exclusion Criteria for all Cohorts: * Females of childbearing potential who are pregnant or breast feeding. * Dialysis within the past year. * History of malignancy, within the last 5 years. * Hypogammaglobulinemia requiring immunoglobulin replacement. * History of autologous or allogeneic stem cell transplant and/or organ transplant. * Prior treatment with cellular therapy, gene therapy and/or T-cell engager therapy. * Known history of HIV infection, or hepatitis B or C virus infections. * Active or untreated latent tuberculosis (TB). * Active or uncontrolled infections. * Nonspecific, overlap, mixed autoimmune diseases not clearly identified into any of the studied cohorts. Exclusion Criteria for LN: * Significant pre-existing damage or rapidly progressive glomerulonephritis (GN). Exclusion Criteria for SLE: * Drug-induced SLE. * Catastrophic antiphospholipid syndrome. * Thrombotic thrombocytopenic purpura. * Active or unstable lupus neuropsychiatric manifestations within last 6 months. Exclusion Criteria for SSc: * Infected digital ulceration or necrosis with signs of infection. * Severe pulmonary hypertension. * History of systemic sclerosis renal crisis within 12 months prior to enrollment. * History of active bleeding related to gastric antral vascular ectasia. Exclusion Criteria for IIM: * Other inflammatory and noninflammatory myopathies. * Severe, irreversible muscle damage. Note: Other protocol defined Inclusion/Exclusion criteria may apply.