Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.
Male or female 16-75 years of age, inclusive.
Stable doses of corticosteroids for at least 4 weeks and other immunosuppressives for 8 weeks.
Creatinine clearance more than or equal to 45 ml/min calculated per the 2021 CKD-EPI Creatinine Equation
Participants must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.
Significant disease-related complications
Active thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA)
Current or prior malignancy, unless the malignancy was treated with curative intent and the participant has no known active malignant disease present for ≥ 5 years prior to enrollment.
Symptomatic congestive heart failure.