Imviva Biotech Presents Data Demonstrating Durable Clinical Responses from Ongoing Phase 1/2 Study of CTA313 in Systemic Lupus Erythematosus at ASGCT 2026

Imviva Biotech Reports Durable CTA313 Responses in SLE Phase 1/2 Study

Imviva Biotech announced encouraging clinical and translational data from its ongoing open-label Phase 1/2 study of CTA313, an investigational dual-targeted CD19/BCMA allogeneic CAR-T cell therapy, for systemic lupus erythematosus (SLE) at the American Society of Gene & Cell Therapy’s Annual Meeting (ASGCT 2026). The study, involving 18 evaluable patients with SLE/lupus nephritis, demonstrated durable clinical responses with a median follow-up of six months. Key findings include 100% of patients achieving an SRI-4 response and 50% reaching DORIS remission in the mixed cohort. In the non-renal SLE sub-cohort, 80% achieved DORIS remission, with 90% of those achieving immunosuppression-free remission, supporting CTA313's potential for sustained disease control through immune reset.

• Robust Efficacy Across SLE Sub-cohorts: CTA313 demonstrated significant clinical activity in SLE, with 100% of 18 evaluable patients achieving an SRI-4 response and 78% reaching Lupus Low Disease Activity State. Notably, 50% achieved DORIS (Definition of Remission in SLE) remission in the overall SLE/lupus nephritis cohort. In the non-renal SLE sub-cohort, 80% achieved DORIS remission, with an impressive 90% of those patients achieving immunosuppression-free remission, indicating deep and sustained disease control.
• Immune Reset Mechanism of Action: The data supports CTA313's mechanism of action involving deep and sustained B-cell depletion, followed by the reconstitution of a predominantly naïve, non-autoimmune B-cell repertoire. This immune reset is believed to underpin the durable clinical remission observed in patients with SLE, with anti-dsDNA autoantibody clearance maintained below detectable levels for up to 12 months, suggesting a fundamental shift in immune function.
• Advanced Allogeneic CAR-T Cell Therapy: CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors, designed for B-cell-mediated autoimmune diseases. It incorporates Imviva's proprietary ANSWER™ inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. As an off-the-shelf solution, it can be manufactured in advance and stored, offering accessibility for patients needing CAR-T cell therapy.

CTA313 Delivers Durable Responses in Systemic Lupus Erythematosus

Recent clinical trials demonstrate expanding therapeutic options for systemic lupus erythematosus, with several novel agents showing promising efficacy and safety profiles across different patient populations. These studies encompass phase 2 and 3 trials, real-world evidence, and innovative cellular therapies.

• POETYK SLE-1 and SLE-2 trials evaluated deucravacitinib, a first-in-class oral selective allosteric tyrosine kinase 2 inhibitor, in global phase 3 randomized controlled trials with patients aged 18-75 years randomized 3:2 to receive active treatment or placebo for 52 weeks, demonstrating efficacy across primary SLE Responder Index-4 endpoint and key secondary endpoints in prior phase 2 PAISLEY SLE trial

• ALLEGORY trial assessed obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody, in 303 adults with active SLE, achieving 76.7% SRI-4 response versus 53.5% with placebo (P<0.001) at week 52, with adverse events occurring in 88.7% of obinutuzumab patients versus 81.5% of placebo patients

• TULIP-1 and TULIP-2 pooled analysis examined anifrolumab 300 mg intravenously in 726 patients, showing DORIS remission rates of 16.2% versus 6.0% in immunosuppressant-inexperienced patients and 14.6% versus 7.3% in immunosuppressant-experienced patients at week 52, with favorable safety profile regardless of prior treatment history

• Telitacicept combination study compared telitacicept 160 mg weekly plus low-dose mycophenolate mofetil versus standard-dose mycophenolate mofetil in 84 patients with active SLE, demonstrating non-inferior SLEDAI-2K reduction with significantly lower infection incidence (23.26% versus 68.29%, P<0.001)

• Bicistronic CD19/22 CAR-T therapy in three pediatric patients with refractory lupus nephritis achieved clinical remission within 3 months in all patients with drug-free maintenance for 9-15 months, though one patient experienced grade 4 cytokine release syndrome with hemophagocytic lymphohistiocytosis requiring intensive management

• Real-world anifrolumab studies across multiple centers showed sustained improvement in SLEDAI-2K, achievement of DORIS remission in 53% and LLDAS in 89% of patients at 12 months, with mucocutaneous manifestations and fatigue responding particularly well to treatment

Addressing Unmet Needs in Systemic Lupus Erythematosus Treatment

Current treatment approaches for systemic lupus erythematosus face significant obstacles that limit therapeutic success and patient outcomes. These challenges stem from the disease's complex pathophysiology, heterogeneous clinical presentations, and the limitations of existing therapeutic options. The field continues to grapple with balancing efficacy and safety while addressing diverse patient needs.

• Disease heterogeneity and monitoring challenges complicate management through diverse clinical presentations and lack of universally accepted tools for measuring disease activity, making standardized treatment approaches difficult to implement

• Limited efficacy of conventional therapies affects 20-30% of patients who fail to respond to standard immunosuppressive treatment, with lupus nephritis remaining the most important predictor of morbidity and mortality despite available interventions

• Significant toxicity burden from current therapies including glucocorticoids, cyclophosphamide, and other immunosuppressants leads to considerable adverse effects that impact long-term patient management and quality of life

• Fixed dosing regimens using weight-based approaches for agents like hydroxychloroquine, mycophenolate mofetil, and azathioprine result in frequent under-dosing, over-dosing, and suboptimal therapeutic outcomes

• Drug resistance development occurs in subset of patients receiving traditional immunosuppressive regimens, leading to poor prognosis and limited alternative treatment options

• Failed targeted therapy trials including large placebo-controlled studies of B-cell-depleting agents rituximab (LUNAR trial) and ocrelizumab (BELONG trial) that failed to meet primary efficacy endpoints for lupus nephritis treatment

• Pediatric data limitations restrict evidence-based treatment decisions for children with SLE, as most therapeutic approaches are derived from adult studies with insufficient pediatric clinical trial data

Dual-Targeted CAR-T: A New Horizon for SLE Remission

Chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of hematologic malignancies, offering unprecedented response rates and durable remissions. Now, this transformative technology is rapidly expanding its reach into the realm of autoimmune diseases, where significant unmet needs persist for patients with severe, refractory conditions. The recent announcement of positive Phase 1/2 data for Imviva Biotech's CTA313 in systemic lupus erythematosus (SLE) represents a pivotal moment in this evolution.

CTA313 stands out as an allogeneic, dual-targeted CD19/BCMA CAR-T cell therapy. Its allogeneic nature is a critical differentiator, addressing the logistical hurdles and manufacturing timelines associated with patient-specific autologous CAR-T products. This "off-the-shelf" potential could dramatically improve accessibility and accelerate treatment for patients who often face progressive, debilitating disease. The dual targeting of CD19 and BCMA, both key B-cell antigens, suggests a comprehensive approach to depleting autoreactive B cells, which are central to SLE pathology. Early clinical data, demonstrating 100% SRI-4 response and high rates of DORIS remission, including immunosuppression-free remission, are highly encouraging, pointing towards a profound and sustained immune reset.

However, the journey for CAR-T in autoimmune diseases is not without its challenges. While initial safety profiles appear favorable, CAR-T therapies are known to induce adverse events such as cytokine release syndrome (CRS), neurotoxicity, and cytopenias, which require careful monitoring and management. Furthermore, a newly recognized local immune effector cell-associated toxicity syndrome (LICATS) has been observed in autoimmune patients receiving CD19-targeting CAR-T, though typically mild and self-limited. The median six-month follow-up, while promising, necessitates longer-term data to fully ascertain the durability of remission and the impact of B-cell reconstitution on disease recurrence. Finally, despite the advantages of an allogeneic platform, the inherent complexity and cost of CAR-T manufacturing and administration remain significant barriers to widespread adoption and equitable access, demanding innovative solutions for reimbursement and delivery.