To describe pregnancy and early maternal and infant outcomes after CAR T-cell therapy for autoimmune disease.
Approach:
Study population: Georg Schett and colleagues reported 14 pregnancies in 13 patients previously treated with CAR T-cell therapy for autoimmune disease.
Pregnancy and infant follow-up: Pregnancies occurred spontaneously. The report included pregnancy course, birth outcomes, newborn immune findings, and infant follow-up.
Key Findings:
Eight healthy babies had been born, five pregnancies were ongoing, and one pregnancy was electively terminated for reasons unrelated to autoimmune disease.
No autoimmune disease flares were reported during pregnancy, including in the eight patients with systemic lupus erythematosus.
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 newborns. CD19-positive B-cell counts and IgG levels were within normal ranges.
During follow-up of one to 18 months, normal development was reported in all eight infants; one had influenza at eight months.
Interpretation:
The researchers described the reported pregnancies as uncomplicated and without disease reactivation, with overall maternal and neonatal outcomes appearing favorable.
Limitations:
The report included only 14 pregnancies in 13 patients.
Infant follow-up was limited to one to 18 months.
The researchers called for pregnancy registries and further studies of fertility effects from lymphodepletion and CAR T-cell treatment.
Conclusion:
These early observations add to limited evidence on pregnancy after CAR T-cell therapy for autoimmune disease.
In an exploratory subgroup analysis of patients with ESR1-mutated tumors, median progression-free survival was 11.1 months with the combination and 5.5 months with imlunestrant alone.
