Adicet Bio reported early human data for its off-the-shelf CAR-T program prula-cel in lupus, showing that the therapy drove complete kidney responses in evaluable lupus nephritis patients and that a substantial fraction met a widely used remission criterion. The company emphasized the absence of serious cytokine release syndrome or neurological events in the reported period. After one year of follow-up in an early-stage study, Adicet said 50% of evaluable patients achieved a complete kidney response, and 54% met remission thresholds. The company also reported that patients stopped using immunosuppressive drugs, suggesting a potential steroid- or drug-sparing effect. Adicet plans to initiate a pivotal study in the fourth quarter, positioning the program as an allogeneic alternative to individualized CAR-T approaches that have faced safety disruptions in other autoimmune trials. For biotech decision-makers, the key next step is whether efficacy durability holds through the pivotal phase while maintaining safety—particularly infection risk and CRS rates typical for cell therapies.
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