Pregnancies after CAR T-cell therapy for autoimmune disease were reported without disease reactivation, according to early data from 14 pregnancies in 13 patients. The findings add to limited evidence on pregnancy after CAR T-cell treatment in patients with autoimmune disease.
Autoimmune diseases disproportionately affect women of childbearing age, while both disease activity and immunosuppressive treatment can complicate pregnancy.
CD19-directed CAR T-cell therapy targets disease-associated B cells and has produced sustained drug-free remission in some patients. However, pregnancy after treatment raises questions about disease relapse without ongoing immunosuppression and whether prolonged maternal B-cell depletion could affect the fetus or newborn.
Georg Schett and colleagues reported 14 pregnancies in 13 patients who had previously received CAR T-cell therapy for autoimmune disease. Eight patients had systemic lupus erythematosus, two had systemic sclerosis, and one each had idiopathic inflammatory myositis, systemic sclerosis-rheumatoid arthritis overlap syndrome, or antiphospholipid syndrome. All pregnancies occurred spontaneously without assisted reproductive technologies.
Eight healthy babies had been born by the time of reporting, five pregnancies were ongoing, and one pregnancy was electively terminated for reasons unrelated to autoimmune disease. Time from CAR T-cell therapy to conception ranged from one to 42 months.
No autoimmune disease flares occurred during the pregnancies, including among the eight patients with lupus. All but one patient remained drug-free or received only prophylactic hydroxychloroquine. The remaining patient developed preeclampsia with changes in proteinuria and renal-retention variables but showed no signs of active lupus nephritis on renal biopsy.
“These data suggest that pregnancies in patients with autoimmune disease who had received CAR T-cell therapy were uncomplicated and without disease reactivation,” the researchers wrote. “The overall maternal and neonatal outcomes appeared to be favorable.”
The eight births occurred at a median gestational age of 37 weeks. Median birth weight was 2,995 g, and Apgar scores were reassuring. No CAR T cells were detected in the newborns, while CD19-positive B-cell numbers and immunoglobulin G levels were within normal ranges. Detailed immune profiling also indicated a physiologically naïve B-cell compartment.
Follow-up ranged from one to 18 months, with normal development reported in all eight. No infections were reported except influenza at eight months in one infant.
The researchers called for pregnancy registries to capture additional outcomes after CAR T-cell therapy and for further studies examining how lymphodepletion and CAR T-cell treatment affect fertility.
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References
- G Schett et al., “Pregnancies in patients with autoimmune disease receiving CAR T-cell therapy,” N Engl J Med, 395, 821 (2026). DOI: 10.1056/NEJMc2607737.
