TOPLINE

Women with autoimmune diseases who underwent CD19 chimeric antigen receptor (CAR) T-cell therapy had uncomplicated pregnancies and delivered healthy neonates at full term without disease relapse. All eight newborns had normal B-cell counts and immunoglobulin G (IgG) levels, with no CAR T cells detected.

METHODOLOGY

• Researchers analyzed 14 pregnancies in 13 women with autoimmune diseases who had received CAR T-cell therapy, of whom eight had systemic lupus erythematosus, two had systemic sclerosis, and one each had idiopathic inflammatory myositis, overlap syndrome, and antiphospholipid syndrome.
• Patients received conditioning therapy with cyclophosphamide at a median dose of 1470 mg and fludarabine at a median dose of 133 mg.
• Conceptions occurred spontaneously without the use of assisted reproductive technologies.
• Outcome measures included maternal disease activity, presence of CAR T cells, neonatal B-cell counts, birth parameters, and developmental assessments.
• Between 2025 and 2026, eight healthy neonates were born, five women were pregnant with anticipated deliveries, and one woman had undergone termination of pregnancy for personal reasons unrelated to autoimmune disease.

TAKEAWAY

• No autoimmune disease relapses occurred during any of the 14 pregnancies, and 12 of the 13 patients remained drug-free or received only prophylactic hydroxychloroquine.
• All births occurred at full-term gestation (median, 37 weeks), with normal birth weights (median, 2995 g), lengths (median, 49.75 cm), and head circumferences (median, 33.25 cm).
• No CAR T cells were detected in any of the eight neonates, and CD19-positive B-cell counts (median, 252 cells/mL) and IgG levels (median, 692 mg/dL) were normal.
• Detailed B-cell and IgG analyses revealed a physiologically naive B-cell compartment in the newborns, with reassuring Apgar scores (median, 10).

IN PRACTICE

“[The study] data suggest that pregnancies in patients with autoimmune disease who had received CAR T-cell therapy were uncomplicated and without disease reactivation. The overall maternal and neonatal outcomes appeared to be favorable. Pregnancies resulted in healthy neonates with a B-cell composition and immunoglobulin levels resembling the typical physiological state of a newborn, with no evidence of neonatal infections,” the authors of the study wrote.

SOURCE

The study was led by Georg Schett, MD, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany. It was published online on July 29, 2026, as a correspondence in The New England Journal of Medicine.

LIMITATIONS

No limitations were discussed in the correspondence.

DISCLOSURES

The study received support from the Deutsche Forschungsgemeinschaft through multiple grants or awards. One author disclosed receiving a Lupus Insight Prize from the Lupus Research Alliance, another author disclosed receiving an Else Kröner Excellence Fellowship from Else Kröner-Fresenius Stiftung, and a third author reported receiving a grant from German Cancer Aid. Additional support was provided by the Staedtler Foundation and donations from the Bendel family and the Bleyl family. Additional author disclosures are reported in the original letter.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.