Description
Inclusion Criteria:
- * Male and female subjects aged between 2-30 years old. The first 3 subjects will be aged ≥ 17. The FDA will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2
- * Serologically active Systemic Lupus Erythematosus that is refractory to treatment
- * Able to tolerate apheresis or already has an apheresis product available for use in manufacturing.
- * ≥ 24 weeks post last Rituximab or related B cell depleting therapy
- * ≥ 12 weeks post last Belimumab / Anifrolumab therapy
- * ≥ 4 weeks post last calcineurin inhibitor treatment
- * For subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment
- * For subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment
- * Adequate organ function
- * Adequate laboratory values
- * Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
- * Subjects must be willing to remiain within 1 hour's drive of Seattle Children's Hospital for 4 weeks following CAR T cell infusion.
- * Subject and/or legally authorized representative has signed the informed consent form for this study
Exclusion Criteria:
- * History or presence of active CNS lupus or other CNS disease
- * Kidney dysfunction requiring renal replacement therapy
- * Pregnant or breastfeeding
- * Insufficient pulmonary reserve including history of COPD, \>10 pack year smoking history or SLE lung disease with hypoxia at rest with oxygen saturation ≤92% on room air
- * Unable to tolerate repletion with any formulation of IgG.
- * Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment.
- * Prior solid organ transplantation.
- * Presence of an active severe infection
- * Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Ages Eligible for Study:
2 Years to 30 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No