CAR T therapy leads to healthy pregnancies, NEJM study finds
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Seven women give birth to healthy newborns after receiving CAR T cell therapy for autoimmune diseases, according to a study published July 29 in the New England Journal of Medicine. The study, led by Georg Schett, finds no disease relapses during pregnancy and normal infant immune development. This is the largest such report, even as five additional pregnancies continue.
The NEJM Report
Researchers led by Georg Schett of Friedrich-Alexander-Universität Erlangen-Nürnberg report on 12 women who underwent CAR T cell therapy for autoimmune diseases, primarily lupus, and later became pregnant. The women, from Germany, Belgium, China, Switzerland, France, and the United States, gave birth in 2025 and 2026. Seven delivered healthy newborns, while five had ongoing pregnancies as of late May. Conception occurred naturally between one month and three and a half years after treatment.
Pregnancy and Infant Health
None of the women experienced a reactivation of their autoimmune disease during pregnancy or after delivery. The newborns had normal birth weights and showed no signs of infection at birth. Their immune protein levels were comparable to those of healthy newborns, and further testing of five infants revealed expected immune cell populations. This contrasts with the elevated risks of miscarriage, preterm birth, and low birth weight associated with untreated autoimmune diseases.
CAR T in Autoimmune Disease
CAR T cell therapy was first developed for cancer, but its application to autoimmune diseases has grown since Schett’s team reported in 2022 that five lupus patients entered remission. The therapy engineers a patient’s T cells to destroy B cells that attack the body’s tissues. Bone marrow later replenishes B cells without the harmful self-reactivity. However, the procedure carries risks of infection and other serious side effects, making pregnancy safety a critical unknown.
What's Next
Schett and colleagues will continue to monitor the mothers and children for long-term health outcomes, including immune development and potential late effects. It remains unclear whether the therapy’s profound immune reset could lead to unforeseen complications in future pregnancies, or whether these findings will hold in a larger cohort.
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CAR T therapy leads to healthy pregnancies, NEJM study finds
