Australian CAR-T and In-Vivo CAR-T Trials Face New Safety Scrutiny
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.
KITE-363 continues recruiting refractory SLE/LN at Concord and St Vincent’s, while CREATE Medicines’ CRT-402 is Australia’s first Phase 1/2 in-vivo CAR-T trial using Monash LNP technology. Novartis and BMS pauses after serious inflammatory and haemophagocytic safety events, including three deaths, intensify questions about IEC-HS, governance, surveillance, infrastructure and future PBS access; early FT819 and other immune-cell-depletion findings remain preliminary.