This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
Age ≥18 years and < 70 years of age.
Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.
Adequate hematologic, renal, liver, cardiac and pulmonary organ function.
Subjects must agree to use acceptable methods of contraception.
Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy.
Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
Severe active or history of central nervous (CNS) involvement.
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM.