China's Jiuke Runjia's in vivo CAR‑T candidate Arnovie101 has demonstrated promising efficacy and a notably mild safety profile in two heavily pre‑treated patients with severe systemic lupus erythematosus (SLE). The therapy, which uses an mRNA‑LNP platform to generate CD19‑targeting CAR‑T cells directly in the body, achieved rapid B‑cell depletion within 6 hours of administration and sustained deep clearance with repeat dosing. This was accompanied by a marked reversal of multi‑organ damage and a significant drop in disease activity scores.

Critically, Arnovie101 exhibited a safety profile that diverges sharply from conventional CAR‑T therapies. Even at doses up to 8 mg – reportedly double the upper limit seen with other in vivo candidates – the only adverse event observed was transient, low‑grade fever. There were no instances of severe cytokine release syndrome (CRS), neurotoxicity (ICANS), or other dose‑limiting toxicities. The combination of rapid efficacy and wide therapeutic window positions Arnovie101 as a potential paradigm shift for treating severe autoimmune diseases.

PharmCube's NextBiopharm® database lists 19 in vivo CAR-T companies developing a total of 22 projects in SLE. Click here to request a free trial for NextBiopharm®.