November 11 2026
ImvivaBio Presents Longer-Term Data from Clinical Studies of CTA313 Allogeneic CAR-T Therapy in Lupus at the American College of Rheumatology Convergence 2026
BOSTON, November 10, 2026 (GLOBE NEWSWIRE) -- ImvivaBio, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced new research findings at the American College of Rheumatology (ACR) Convergence 2026, November 6-11, in Orlando, Florida. Shared in four poster presentations, the data, which include follow-up of up to 12 months, highlight CTA313, its investigational dual-targeted CD19/B-cell maturation antigen (BCMA) allogeneic CAR-T cell therapy in systemic lupus erythematosus (SLE) and lupus nephritis (LN).
Current standard-of-care treatments for SLE and LN rely on broad immunosuppression, and many patients still experience incomplete responses, recurrent flares, and long-term treatment-related toxicity. These limitations highlight the need for novel approaches that address underlying immune dysfunction and provide sustained disease control.
“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. “We believe these findings show the potential of CTA313 as an off-the-shelf approach to durable disease control in lupus, and they support its evaluation in the upcoming global Phase 1b ALLNEW basket study.”
The analysis pooled Phase 1 data from 14 heavily pretreated patients with refractory SLE and minimal renal involvement, who had received a median of five prior therapies, with 86.7% receiving concomitant tacrolimus. CTA313 showed dose-dependent expansion across the 3, 6, and 10 x 106 cells/kg dose levels. B cells fell from a median of 52.2 to 0 cells/µL by Day 7, then reconstituted around Day 42 with a predominantly naive phenotype. Anti-double-stranded DNA (anti-dsDNA) antibodies became undetectable by Month 3, and complement component (C3) rose from 0.65 to 1.34 g/L by Day 28. SLE Responder Index-4 (SRI-4) response reached 91% and Definition of Remission in SLE (DORIS) remission reached 73% at Month 6 (n=11), and DORIS remission reached 88% at Month 12 (7/8 patients). At Month 6, 92% of evaluable patients (n=12) were taking glucocorticoids at 5 mg/day or less, and 92.9% of patients (13/14) were off immunosuppressants at data cutoff.
The safety profile was manageable, with cytokine release syndrome (CRS) in 35.7% of patients (all Grade 1) and no neurotoxicity or graft-versus-host disease (GvHD). The most common Grade 3 or higher adverse events were neutropenia (71.4%), thrombocytopenia (21.4%), and infections (21.4%). These data suggest the potential of allogeneic-CAR-T in SLE and support evaluation in the upcoming global Phase 1b ALLNEW study.
The data describe the immune-reset mechanism of CTA313, an off-the-shelf allogeneic CAR-T therapy targeting both CD19 and BCMA, in patients with active SLE, with or without LN. The rationale is that targeting a single antigen may leave autoreactive B-cell precursors or plasma-cell reservoirs untouched, which could lead to relapse. After infusion, CTA313 expanded and produced deep but reversible B-cell depletion, with reconstituted B cells more than 95% naive, and single-cell analysis of two patients showed no overlap between the pretreatment autoreactive clones and the newly formed clones. Anti-dsDNA antibodies remained undetectable for up to one year, and complement levels (C3 and complement component 4) normalized.
Clinically, 69% of patients reached low-dose glucocorticoid use (5 mg/day or less), immunosuppression-free remission occurred in 61% of patients with SLE/LN and 90% of those with non-renal SLE, DORIS remission exceeded 70% from Month 3 through Month 12 in non-renal SLE, and 50% (7/14) of LN patients achieved complete renal remission at Month 4. Together, these results point to dual CD19/BCMA targeting as a driver of immune reset and inform the design of ImvivaBio’s ALLNEW study.
“For patients with lupus, sustained DORIS remission is the outcome that matters most, and it is encouraging to see it accompanied by biological changes that are consistent with an immune reset,” said Ben Capoccia, PhD, Director of Translational Medicine and Clinical Research, ImvivaBio. “We believe this alignment between the clinical and translational data supports the potential of CTA313 for durable disease control.”
ImvivaBio’s presentations at ACR also highlight how dual-target CD19/BCMA CAR-T compares with single-target CD19 approaches, as well as CTA313’s results in lupus nephritis.
Data compare single-target CD19 (n=17) and dual-target CD19/BCMA (n=27) allogeneic CAR-T approaches from separate Phase 1 studies in patients with SLE and LN. The dual-target product demonstrated deeper B-cell depletion and, in SLE with minimal renal involvement, reached DORIS remission in 80% of patients at Month 12, compared with 20% for the single-target product. Safety was comparable, with notably no immune effector cell-associated neurotoxicity syndrome (ICANS) observed with either, no Grade 3 or higher CRS with dual-target, and Grade 3 or higher infection rates of 11.1% for dual-target versus 11.8% for single-target, although hypogammaglobulinemia was more frequent with dual-target (85% versus 12%), consistent with deeper plasma-cell depletion. These data suggest that dual targeting may represent a more effective immune-reset strategy.
CTA313 was evaluated in 16 patients with LN as of June 1, 2026. At the latest visit (n=16), 93.8% achieved SRI-4 or better, 62.5% achieved Lupus Low Disease Activity State or DORIS, and 31.3% achieved DORIS remission. Overall, 69% (11/16) achieved complete renal response at one or more post-baseline visits, and 43.8% (7/16) were in complete renal response at the latest visit. At Month 9, 92% of evaluable patients (n=12) were taking glucocorticoids at 5 mg/day or less. CRS occurred in 62.5% of patients, none Grade 3 or higher, with notably no ICANS or GvHD observed; two patients received tocilizumab. In patients with LN, these results show consistent, clinically meaningful responses, including steroid sparing and renal improvement, and point to a potential immune-reset mechanism.
Abstracts are currently available to the public at: https://acrabstracts.org/meetings/acr-convergence-2026/?viewby=title
For more information, visit www.imvivabio.com.
About CTA313
CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors and designed for B-cell-mediated autoimmune diseases. The product incorporates Imviva's proprietary ANSWER™ inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. CTA313 can be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution for patients in need of CAR-T cell therapy. The therapy has been evaluated in an open-label Phase 1/2 study across multiple autoimmune indications in China, including renal, rheumatologic, endocrine, gastrointestinal, hematology, and autoimmune conditions.
About ImvivaBio
ImvivaBio is a clinical-stage biotechnology company dedicated to developing innovative allogeneic CAR-T cell therapies for patients with cancer and autoimmune diseases. The company's proprietary platform incorporates advanced cell engineering technologies to create off-the-shelf cellular immunotherapies. Imviva’s pipeline includes programs in both oncology and autoimmune indications.
Forward-Looking Statements
This press release contains forward-looking statements regarding product development and potential. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied.
Contacts:
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ICR Healthcare
ImvivaBiotechIR@icrhealthcare.com
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Ally Stubin
ICR Healthcare
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(646) 667-1861