A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

Eligibility Criteria

• 1. Age ≥18 years and \< 70 years of age.
• 2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.
• 3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function.
• 4. Subjects must agree to use acceptable methods of contraception.
• 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.
• 6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM).
• 1. Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy.
• 2. Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• 3. Severe active or history of central nervous (CNS) involvement.
• 4. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM.
• 5. Mixed connective tissue disease with no clear predominant disease.
• 6. Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and/or confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.
• 7. History of primary or secondary immunodeficiency.
• 8. Presence or history of certain bacterial, viral or fungal infection.
• 9. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).
• 10. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.
• 11. History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation.
• 12. Pregnant or lactating.
• 13. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.