KITE-363 CAR-T Trial at Australian Sites for Refractory Lupus
Key Questions
What is the KITE-363 CAR-T trial and where is it recruiting patients in Australia?
KITE-363 is a Phase 1 trial (NCT07038447) recruiting patients with refractory SLE or lupus nephritis at Concord Hospital in Sydney and St Vincent's Hospital in Melbourne. It is supported by global safety data on BCMA-CD19 CAR-T therapies showing reduced autoantibodies.
What recent EULAR 2026 data supports CAR-T use in SLE?
Data presented at EULAR 2026 indicate that zorpocabtagene autoleucel can reshape gut microbiota, while CD19/BCMA CAR-T improves skin and lung fibrosis in SLE. The Erlangen series showed only 1 relapse in 28 patients and sustained DORIS remission in all 8 treated SLE cases.
Which other CAR-T therapies have received recent regulatory designations for lupus?
Imviva's CTA313 allogeneic CD19/BCMA CAR-T received FDA IND approval with 100% SRI-4 response in SLE, while AbelZeta's C-CAR168 CD19/BCMA CAR-T was granted EMA PRIME designation in November 2026. Fate Therapeutics' FT-839 dual-target CAR-T also received IND clearance.
What real-world evidence exists for CAR-T in autoimmune diseases?
UK NHS real-world evidence shows CAR-T inducing remission in autoimmune patients, strengthening the case for Australian PBS advocacy. A new systematic review from November 2026 consolidates evidence for CAR-based therapies in refractory SLE.
What allogeneic CAR-T options are mentioned for SLE treatment?
Allogeneic FT819 from Fate Therapeutics demonstrated 24-month efficacy, and Imviva's CTA313 showed strong response rates. These approaches address scalability challenges alongside the immune dimming concept discussed in the trial context.
Phase 1 trial (NCT07038447) recruiting refractory SLE/LN at Concord (Sydney) and St Vincent's (Melbourne). Bolstered by global BCMA-CD19 CAR-T safety data showing reduced autoantibodies. New EULAR 2026 data: zorpocabtagene autoleucel reshapes gut microbiota, CD19/BCMA CAR-T improves skin/lung fibrosis in SLE. Additional EULAR 2026 recap: Erlangen series shows only 1/28 SLE patients relapsed, all 8 SLE patients sustained DORIS remission; allogeneic FT819 (Fate Therapeutics) showed 24-month efficacy. Immune dimming concept and scalability challenges discussed. Imviva's CTA313 allogeneic CD19/BCMA CAR-T received FDA IND approval with 100% SRI-4 response in SLE. Autolus Therapeutics' obe-cel shows early promise in severe SLE (CARLYSLE trial). UK NHS real-world evidence of CAR-T inducing remission in autoimmune patients strengthens precedent for Australian PBS advocacy. A new systematic review on CAR-based cellular therapy for refractory SLE (Nov 2026) consolidates current evidence. Fate Therapeutics' FT-839 (CD19/CD38 dual-target CAR-T) received IND clearance. AbelZeta's CD19/BCMA CAR-T received EMA PRIME designation (Nov 2026) and now FDA clearance for registrational Phase II in refractory LN (Dec 2026), further reinforcing global CAR-T momentum. Roche dropped its TCE for lupus but continues autoimmune cell therapy development via Poseida – a minor setback but pipeline remains active.