Pregnancies Reported After CAR T-Cell Therapy for Autoimmune Disease

Overview

An early report described 14 pregnancies in 13 patients who had received CAR T-cell therapy for autoimmune disease. No autoimmune disease flares were reported during pregnancy; eight healthy infants had been born at the time of reporting, with five pregnancies ongoing and one electively terminated for reasons unrelated to autoimmune disease.

Background

Autoimmune diseases disproportionately affect women of childbearing age, while 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. Pregnancy after treatment raises questions about disease relapse without ongoing immunosuppression and whether prolonged maternal B-cell depletion could affect the fetus or newborn. Evidence on pregnancy after CAR T-cell therapy remains limited.

Data Highlights

Key Findings

• The cohort comprised 14 spontaneous pregnancies in 13 patients; none used assisted reproductive technologies.
• No autoimmune disease flares were reported during pregnancy, including among the eight patients with systemic lupus erythematosus.
• One patient developed preeclampsia with changes in proteinuria and renal-retention variables; renal biopsy showed no active lupus nephritis.
• Eight infants had been born at the time of reporting. No CAR T cells were detected in newborns, and reported CD19-positive B-cell counts and IgG levels were within normal ranges.
• All eight infants had normal development reported during follow-up of 1–18 months; one infant had influenza at eight months, and no other infections were reported.
• The researchers called for pregnancy registries and further studies of the effects of lymphodepletion and CAR T-cell treatment on fertility.

Conclusion

In this small report, pregnancies after CAR T-cell therapy for autoimmune disease were not accompanied by reported disease flares, and early outcomes among the eight infants born were described as favorable. Larger registries and further fertility research are needed, as the authors noted.

Related Resources & Content

1. Schett G, et al., New England Journal of Medicine, 2026 — Pregnancies in Patients with Autoimmune Disease Receiving CAR T-Cell Therapy
2. American Society of Clinical Oncology, Journal of Clinical Oncology, 2025 — Management of Cancer During Pregnancy: ASCO Guideline
3. The ASCO Post — Early Findings From First Human Study of In Vivo CAR T in Myeloma
4. The ASCO Post — AACR 2018: Off-the-Shelf, Dual-Targeted CAR T-Cell Product Showed Promising Results in Preclinical Studies Key Points
5. the medicine maker — This Week’s CGT News: Promising Data for In Vivo CAR T
6. the asco post — A Look at Tomorrow’s CAR T-Cell Therapy Today
7. Pregnancies in Patients with Autoimmune Disease Receiving CAR T-Cell Therapy
8. Management of Cancer During Pregnancy: ASCO Guideline
9. Management of Cancer During Pregnancy: ASCO Guideline | Journal of Clinical Oncology
10. Pregnancies in Patients with Autoimmune Disease Receiving CAR T-Cell Therapy | New England Journal of Medicine
11. Fertility management and outcomes after CAR T-cell therapy: an international survey from the Cellular Therapy and Immunobiology working party of the European Society for Blood and Marrow Transplantation - PubMed