Imviva Highlights Early Remission Data for Allogeneic CAR-T Therapy in Lupus at ASGCT 2026

Imviva Biotech presented updated clinical and translational data from its ongoing Phase 1/2 study evaluating CTA313, an investigational dual-targeted CD19/BCMA allogeneic CAR-T therapy, in systemic lupus erythematosus (SLE) during the American Society of Gene & Cell Therapy Annual Meeting, held May 11–15 in Boston.¹

According to the company, all 18 evaluable patients with SLE or lupus nephritis achieved an SRI-4 response following treatment with CTA313 at a median follow-up of six months.¹ Additionally, 78% of patients achieved Lupus Low Disease Activity State, while half met DORIS remission criteria.¹

While CAR-T therapies have been primarily associated with hematologic oncology, investigators have increasingly explored B-cell-directed cellular therapies for autoimmune disorders characterized by pathogenic autoantibody production.² CTA313 targets both CD19 and BCMA, markers expressed on B cells and plasma cells implicated in lupus disease activity.

Imviva also reported encouraging findings within a non-renal SLE subgroup. According to the company, 80% of those patients achieved DORIS remission, and 90% of responders maintained remission without ongoing immunosuppressive therapy.¹ Investigators additionally observed sustained suppression of anti-double stranded DNA autoantibodies for up to 12 months.

“These outcomes, together with deep B-cell depletion and sustained suppression of pathogenic autoantibodies, support CTA313’s potential to deliver durable disease control through immune reset,” said Ben Capoccia, director of translational medicine and clinical research at Imviva Biotech, in a company statement.¹

“Immune reset” mechanism draws industry interest

The company stated translational analyses suggest CTA313 induces profound B-cell depletion followed by reconstitution of predominantly naïve, non-autoimmune B-cell populations.¹ Researchers continue investigating whether this type of immune “reset” may provide more durable disease control than chronic immunosuppressive approaches currently used in lupus management.

Interest in CAR-T therapy for autoimmune disease has accelerated in recent years following early academic reports demonstrating prolonged remission in refractory lupus patients treated with CD19-directed CAR-T therapies.^2,3 Multiple ongoing studies are now evaluating cellular immunotherapy approaches across autoimmune indications, including lupus nephritis and systemic autoimmune disorders.⁴ Regulatory agencies are also closely monitoring emerging long-term outcomes.

CTA313 is designed as an allogeneic, or donor-derived, CAR-T product incorporating proprietary genetic engineering technologies intended to improve persistence and reduce host immune rejection.¹ Unlike autologous CAR-T therapies, allogeneic platforms may offer off-the-shelf manufacturing and broader scalability.

References

1. Imviva Biotech presents data demonstrating durable clinical responses from ongoing Phase 1/2 study of CTA313 in systemic lupus erythematosus at ASGCT 2026. (2026, May 14). GlobeNewswire. https://www.globenewswire.com/news-release/2026/05/14/3071107/0/en/Imviva-Biotech-Presents-Data-Demonstrating-Durable-Clinical-Responses-from-Ongoing-Phase-1-2-Study-of-CTA313-in-Systemic-Lupus-Erythematosus-at-ASGCT-2026.html
2. Mougiakakos, D., Krönke, G., Völkl, S., et al. (2021 Aug 5). CD19-targeted CAR T cells in refractory systemic lupus erythematosus. N Engl J Med. https://pubmed.ncbi.nlm.nih.gov/34347960/
3. Mackensen, A., Müller, F., Mougiakakos, D., et al. (2022 Sep 15). Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nature Medicine. https://www.nature.com/articles/s41591-022-02017-5
4. CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus (2026). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07432334