Adicet reports encouraging early lupus CAR-T data as shares fall

Adicet Bio reported Phase 1 results for prulacabtagene leucel (prula-cel, formerly ADI-001), an investigational off-the-shelf CAR-T therapy, in 22 people with lupus:
16 with lupus nephritis and six with extra-renal systemic lupus erythematosus.

Among patients assessed at 12 months, 50% of evaluable lupus-nephritis patients had a complete renal response, while 54% of evaluable patients achieved DORIS remission. All 22 had at least six months of follow-up; 13 had at least 12 months.

Despite the encouraging early findings, reports said Adicet shares fell sharply after the announcement—roughly 24% in one report, with premarket losses cited at about 38%. The available results do not establish a single definitive reason for the drop; small Phase 1 numbers and the need for larger, controlled studies are important caveats.

The company said it planned to begin start-up activities for a pivotal study in the fourth quarter of 2026. These results are preliminary and do not show that prula-cel is proven or approved for lupus.