Imviva's Allogeneic CAR-T Therapy CTA313 Achieves 100% Response Rate in Systemic Lupus Erythematosus Trial
核心洞察
Imviva Biotech (搜索)'s CTA313 (搜索), a dual-targeted CD19 (搜索)/BCMA (搜索) allogeneic CAR-T therapy, demonstrated 100% SRI-4 response rate in 24 patients with systemic lupus erythematosus at median 6-month follow-up.
The therapy achieved profound B-cell depletion followed by repopulation with healthy naïve B cells, suggesting an "immune-reset" mechanism that may enable prolonged remission.
CTA313 (搜索) showed favorable safety profile with only Grade 1 cytokine release syndrome in 41.7% of patients and no cases of severe neurotoxicity or graft-versus-host disease.
Imviva Biotech (搜索)'s investigational allogeneic CAR-T cell therapy CTA313 (搜索) has demonstrated unprecedented clinical efficacy in patients with systemic lupus erythematosus (SLE), achieving a 100% response rate in an ongoing Phase 1/2 trial. The dual-targeted CD19 (搜索)/BCMA (搜索) therapy represents a potential breakthrough in autoimmune disease treatment, offering an off-the-shelf cellular immunotherapy approach that could transform patient care.
Clinical Trial Results Show Remarkable Efficacy
The open-label Phase 1/2 study enrolled 24 patients with active or refractory SLE and lupus nephritis, including 14 patients (58.3%) with lupus nephritis. At a median follow-up of 6 months, CTA313 (搜索) demonstrated robust clinical outcomes with 100% of patients achieving SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response. Additionally, 73.7% of patients achieved LLDAS (Low Lupus Disease Activity State), and 42.1% achieved DORIS (Definition of Remission in SLE) remission at the last follow-up with a deepening trend.
Particularly notable was the achievement of immunosuppression-free remission or glucocorticoid dose reduction to ≤10 mg/day in 83.3% of patients, addressing a critical unmet need for lupus patients who typically require chronic immunosuppression.
Immune-Reset Mechanism Demonstrates Therapeutic Potential
CTA313 (搜索) produced profound and sustained B-cell depletion followed by repopulation dominated by a naïve phenotype with limited memory/activated subsets. Anti-dsDNA antibodies declined rapidly to undetectable levels and remained suppressed through follow-up, while anti-Rubella vaccine titers remained undetectable. These findings provide evidence of an "immune-reset" mechanism—fundamental immune system restoration that may enable prolonged remission in autoantibody-mediated autoimmune disease.
"The concept of immune-reset—where patients achieve deep, durable remission with repopulation by healthy, naïve B cells—demonstrates the transformative potential of our ANSWER platform," said Lu Han, Chief Executive Officer of Imviva Biotech (搜索). "This is particularly meaningful for patients with lupus and other autoimmune diseases, who often face limited treatment options and the burden of chronic immunosuppression."
Favorable Safety Profile in Allogeneic Setting
CTA313 (搜索) demonstrated a favorable safety profile with cytokine release syndrome occurring in 41.7% of patients at Grade 1. No cases of immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, or lupus-induced cytokine-associated toxicity syndrome were reported. Infections occurred in 20.8% of patients overall, with Grade 3 or higher infections in 12.5%.
Advanced Platform Technology Enables Off-the-Shelf Therapy
CTA313 (搜索) incorporates Imviva's proprietary ANSWER™ (Antibody SWitch Engineered Receptor) platform, which enables enhanced pharmacokinetic persistence and improved therapeutic durability in the allogeneic setting. The therapy incorporates multiple genetic edits—including CIITA (Class II transactivator) knockout to prevent host immune rejection and T-cell receptor (TCR) knockout to prevent graft-versus-host disease—alongside dual targeting of CD19 (搜索) and BCMA (搜索) (B-cell maturation antigen).
The allogeneic approach allows CTA313 (搜索) to be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution that could significantly improve access to CAR-T cell therapy for autoimmune disease patients.
Presentation at European Lupus Meeting
The clinical results will be presented as a late-breaking short oral presentation at the 15th European Lupus Meeting (ELM 2026) by Chief Medical Officer Jan Davidson-Moncada, M.D., Ph.D. The presentation is scheduled for March 6, 2026, at 14:01–14:09 CET during the Late Breaking session in Lisbon, Portugal.
"These clinical results represent a significant advancement in our understanding of allogeneic CAR-T therapy for autoimmune disease," said Han. "We believe CTA313 (搜索) has the potential to change the treatment paradigm in autoimmune disease."
The therapy has been evaluated across multiple autoimmune indications in China, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and idiopathic inflammatory myopathy, suggesting broad therapeutic potential across B-cell-mediated autoimmune diseases.