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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Test CRT-402 in Refractory Autoimmune Disease
