AT the ACR Convergence 2025 meeting, investigators presented interim findings from a trial of CTA313, a “universal” CAR-T cell product engineered to target both CD19 and BCMA. This dual-target approach may offer a novel therapeutic option for patients with active systemic lupus erythematosus (SLE) who have failed conventional therapies.
What is CTA313 and how does it work?
CTA313 is an off-the-shelf CAR-T cell therapy designed to deplete both autoreactive B cells (via CD19 ) and long-lived plasma cells (via BCMA), combined with genetic modifications to resist rejection and increase persistence. According to the abstract, the CAR-T product features T-cell receptor knockout, HLA class I knockout and ANSWER™ inhibitory molecule over-expression, an advanced construct enabling durable in-vivo activity.
Early trial results spark hope
In the trial, 7 patients with refractory active SLE received a single infusion of CTA313 following lymphodepletion (cyclophosphamide and fludarabine). Six (86 %) were female, median age was 43 years and median disease duration was 6 years. Two of the patients had lupus nephritis.
Safety so far appears acceptable: Grade 1 cytokine-release syndrome (CRS) occurred in four patients, and no instances of neurotoxicity, graft-versus-host disease or serious infections were reported. Some hypogammaglobulinaemia was observed, but was manageable.
Among the five evaluable patients, all achieved a SRI-4 response and four attained Lupus Low Disease Activity State (LLDAS). Strikingly, three patients discontinued all immunosuppressive medications, including glucocorticoids, reaching what appears to be drug-free remission. Autoantibody levels fell and complement C3 levels rose; proteinuria improved in those with nephritis.
What this means for lupus care
The dual-target CAR-T strategy tackles both B-cell and plasma-cell compartments implicated in SLE, offering a more comprehensive immune reset. The promising safety and efficacy data suggest that CTA313 may shift the treatment paradigm beyond traditional immunosuppression.
However, limitations should be noted: the sample size is small, follow-up remains early, and long-term outcomes, including durability, relapse risk and cost–benefit, are yet to be defined.
Looking ahead
Researchers plan dose escalation, expanded cohorts and longer-term follow-up to clarify durability and identify optimal patient profiles. If results are sustained, CTA313 could offer a one-time or limited-dose treatment aiming at durable remission in lupus, fundamentally altering disease management.
Reference
Wang H et al. Preliminary Safety, Efficacy, and Cellular Kinetics of CTA313, a CD19/BCMA Dual-Targeted Universal CAR-T Therapy, for Active Systemic Lupus Erythematosus. Poster 1532. ACR Convergence, 25th-29th October, 2025.
