Successful Spontaneous Pregnancies and Healthy Neonates After Dual‐Target CAR –T Cell Therapy in Systemic Lupus Erythematosus

OBJECTIVE: Dual-target CAR-T cell therapy targeting BCMA and CD19 is an emerging and promising treatment for systemic lupus erythematosus (SLE). However, its effects on fertility and neonatal safety are largely unknown. This report describes the outcomes of two successful pregnancies and deliveries in a patient with SLE treated with BCMA/CD19 CAR-T cell therapy. METHODS: A 24-year-old woman with class IV lupus nephritis received BCMA/CD19 CAR-T cell therapy. The patient achieved sustained molecular remission of SLE and became pregnant spontaneously at 6-months and 21-months postinfusion. We monitored for CAR-T cell presence in maternal and neonatal samples and assessed the health of the infants. RESULTS: Lupus activity remained minimal without flares throughout both pregnancies. The patient had two term vaginal deliveries of healthy female infants. Serial digital polymerase chain reaction analysis of the patient's blood, breast milk, and placenta, as well as the infants' blood at birth and during follow-up, were all uniformly negative for CAR-T cell DNA. Both infants showed normal growth, neurodevelopment, and immune function at follow-up, with no evidence of CAR-T cell transmission. The patient's self-reported quality of life also improved significantly after the therapy. CONCLUSION: This case suggests that BCMA/CD19 CAR-T cell therapy may induce sustained remission (over 30 months) in SLE, preserve fertility, and result in healthy pregnancies and neonates. This finding highlights the need for evidence-based guidelines for patients considering pregnancy after CAR-T cell therapy.