Adicet Bio's experimental CAR-T therapy, prula-cel, has shown early signs of effectiveness against lupus, according to data from a small phase 1 trial. Among patients with lupus nephritis who were evaluable for efficacy, half achieved a complete kidney response and 54% met a standard remission criterion after a year of follow-up. All of these patients had previously failed multiple treatments and were able to stop taking immunosuppressive drugs entirely.
The therapy is notable because it is allogeneic—derived from donor cells—rather than personalized, making it faster and cheaper to manufacture. It also uses gamma delta T cells, which the company says secrete fewer inflammatory cytokines than the alpha beta T cells used in most other CAR-T approaches. This may explain why no serious cases of cytokine release syndrome or neurological side effects were observed, though infections occurred in more than half of patients, with 8% experiencing grade 3 or higher severity.
The results come weeks after Novartis and Bristol Myers Squibb paused trials of their individualized CAR-T therapies due to worrisome side effects, including a rare immune reaction that led to deaths. Analysts called the Adicet data "impressive" and noted the complete response rate exceeded the roughly 40% seen with competing cell therapies. Still, investors were unimpressed—shares dropped 22% by mid-morning—and the company plans to discuss a broader pivotal study with regulators, potentially including patients without lupus nephritis.