Clinical and immunologic status of a child conceived following maternal administration of CD19 CAR T-cells for systemic lupus erythematosus

OBJECTIVES: To report pregnancy outcome and neonatal immune parameters following early conception after maternal CD19 chimeric antigen receptor T-cell (CAR-T) therapy for refractory systemic lupus erythematosus (SLE). METHODS: Maternal and neonatal CAR-T cells were assessed by transgene polymerase chain reaction (PCR) at delivery. CD19+ B-cell counts and immunoglobulin levels were measured in maternal and neonatal blood at birth. Infant health outcomes were assessed during the first year of life. RESULTS: Conception occurred approximately seven weeks after CD19 CAR-T infusion. CAR-T cells were not detected in maternal peripheral blood or cord blood at delivery. Neonatal CD19+ B-cell counts and IgG levels were within age-appropriate reference ranges and exceeded maternal values, which remained subnormal. During one year of follow-up, the infant experienced no recurrent or severe infections. CONCLUSIONS: This case represents the earliest reported pregnancy following CD19 CAR-T therapy for SLE and the first to include neonatal immune assessment at birth. No evidence of transplacental CAR-T transfer or clinically significant neonatal immunodeficiency was observed. Additional cases and long-term follow-up are required to guide reproductive counseling after CAR-T therapy.