
Adicet Bio: Prula-cel Shows Positive SLE/LN Phase 1 Data
Adicet Bio announced positive safety and efficacy data from its Prula-cel Phase 1 study in patients with systemic lupus erythematosus (SLE) with or without lupus nephritis (LN). The data showed high rates of immunosuppressant-free responses, with 50% of lupus nephritis patients achieving complete renal response and 54% of evaluable patients achieving DORIS remission at 12 months. Prula-cel demonstrated a favorable safety profile with no severe cytokine release syndrome (CRS), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), or immune effector cell-associated neurotoxicity syndrome (ICANS). The company plans to initiate pivotal study start-up activities in Q4 2026.
Key Highlights
- Adicet Bio announces positive safety and efficacy data from Prula-cel Phase 1 study in SLE patients.
- At 12-month mark, 50% of lupus nephritis patients achieved complete renal response (CRR).
- 54% of evaluable patients achieved DORIS remission at 12 months.
- No cytokine release syndrome (CRS) greater than Grade 2 observed in 24 safety-evaluable patients.
- All patients discontinued immunosuppressants; all but one tapered steroids to ≤5 mg prednisone equivalent.
- Company plans to initiate start-up activities for a pivotal study in lupus nephritis in Q4 2026.
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