ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months

ImvivaBio’s CTA313, an off-the-shelf allogeneic CAR-T cell therapy that targets both CD19 and B-cell maturation antigen (BCMA), produced remission rates that held through 12 months of follow-up in patients with refractory systemic lupus erythematosus (SLE), according to longer-term Phase 1 data presented at the American College of Rheumatology (ACR) Convergence 2026.¹ In a pooled analysis, 88% of evaluable patients (7 of 8) were in Definition of Remission in SLE (DORIS) remission at Month 12.¹

“Our data now extend to 12 months of follow-up, and highlight that deep B-cell depletion, repopulation with naive B cells, and remission continue through Month 12,” said Jan Davidson-Moncada, MD, PhD, chief medical officer of ImvivaBio.¹

Why target both CD19 and BCMA?

CD19-directed CAR-T therapy has shown striking results in autoimmune disease. In a 2024 case series in The New England Journal of Medicine, all eight patients with SLE treated with autologous CD19 CAR-T cells reached DORIS remission, and all 15 patients across three autoimmune diseases were able to stop immunosuppressive therapy.²

CD19-targeted therapies, however, do not eliminate long-lived plasma cells, which can “continue producing autoantibodies despite B-cell depletion,” according to a 2021 report on BCMA-CD19 compound CAR-T in SLE.³ BCMA is expressed on plasma cells, so adding it as a second target is intended to clear both B cells and the plasma cells that produce autoantibodies.³

CTA313 is derived from healthy donor cells and incorporates ImvivaBio’s ANSWER inhibitory ligands and genetic edits designed to resist host immune rejection and improve durability.¹ Because it can be manufactured in advance and stored, a single batch can be used for multiple patients.¹

That approach addresses a known limitation of autologous products. In a BioPharm International® Q&A on advanced therapies, Anna Catalanotto, director of advanced therapy commercial strategy at Cardinal Health, said, “The manufacturing complexities can have a significant impact to patient access to these therapies.”

What did the studies show?

In a pooled phase 1 analysis of 14 heavily pretreated patients with refractory SLE and minimal renal involvement, who had received a median of five prior therapies, B-cell counts fell to zero by Day 7 and anti-double-stranded DNA antibodies became undetectable by Month 3.¹ At Month 6, 91% of evaluable patients (n=11) achieved an SLE Responder Index-4 (SRI-4) response and 73% reached DORIS remission.¹ Thirteen of 14 patients were off immunosuppressants at Month 6.¹

In a separate study of 16 patients with lupus nephritis, 93.8% achieved an SRI-4 response and 43.8% achieved a complete renal response at their latest visit.¹

ImvivaBio also compared results from separate phase 1 studies of a single-target CD19 CAR-T (n=17) and its dual-target product (n=27).¹ In SLE with minimal renal involvement, 80% of patients receiving the dual-target therapy were in DORIS remission at Month 12, compared with 20% receiving single-target CD19.¹ Because the studies were not head-to-head, the comparison should be interpreted with caution.

“For patients with lupus, sustained DORIS remission is the outcome that matters most,” said Ben Capoccia, PhD, director of translational medicine and clinical research at ImvivaBio.¹

What about safety?

In the pooled SLE analysis, cytokine release syndrome occurred in 35.7% of patients, all Grade 1, with no neurotoxicity or graft-versus-host disease.¹ Grade 3 or higher adverse events included neutropenia (71.4%), thrombocytopenia (21.4%), and infections (21.4%).¹ Hypogammaglobulinemia was more common with the dual-target product than with single-target CD19 CAR-T (85% vs 12%), and Grade 3 or higher infections occurred at similar rates (11.1% vs 11.8%).¹

What happens next?

The data support evaluating CTA313 in ALLNEW, an upcoming global Phase 1b basket study, according to the company.¹ The results build on earlier data the company presented at the American Society of Gene & Cell Therapy Annual Meeting in May, as BioPharm International reported.

References

1. ImvivaBio presents longer-term data from clinical studies of CTA313 allogeneic CAR-T therapy in lupus at the American College of Rheumatology Convergence 2026. News release. ImvivaBio; November 11, 2026. Accessed November 11, 2026.
2. Müller F, Taubmann J, Bucci L, et al. CD19 CAR T-cell therapy in autoimmune disease: a case series with follow-up. N Engl J Med. 2024;390(8):687-700. doi:10.1056/NEJMoa2308917
3. Zhang W, Feng J, Cinquina A, et al. Treatment of systemic lupus erythematosus using BCMA-CD19 compound CAR. Stem Cell Rev Rep. 2021;17(6):2120-2123. doi:10.1007/s12015-021-10251-6