Can engineered immune cells tame lupus? new trial hopes so.

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 remain 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