A Study to Test CRT-402 in Refractory Autoimmune Disease

Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies. CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset. This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).

Inclusion Criteria: * Age 18 years or older. * Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy. * Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria. * Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing. * Females of childbearing potential must have a negative pregnancy test before treatment. * Must be willing and able to attend study visits and follow all study requirements. Exclusion Criteria: * Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator, * Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data, * Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy, * History of bone marrow/ hematopoietic stem cell or solid organ transplantation, * Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis, * Pregnancy or lactation.