A Study to Test CRT-402 in Refractory Autoimmune Disease

This is a multicenter, open-label, Phase 1/2, first-in-human, dose escalation and expansion study designed to assess the safety and tolerability, as well as define the recommended Phase 2 dose (RP2D) of CRT-402 in participants with refractory autoimmune disease.

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.