Adicet Bio CAR-T sparks lupus remissions in early-stage trial

Key Points:

• Adicet Bio's off-the-shelf CAR-T cell therapy prula-cel induced remission in over half of lupus patients in a small phase 1 trial, with 12 of 22 patients achieving symptom remission and 8 of 16 with lupus nephritis seeing kidney symptom remission one year after treatment.
• The therapy showed a strong safety profile, with no cases of serious side effects like immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) or immune effector cell-associated neurotoxicity syndrome (ICANS), and mostly mild cytokine release syndrome (CRS).
• Prula-cel uses gamma delta T cells, which naturally reside in tissues and target CD20 on B cells, aiming to reset the immune system by producing naive B cells that do not cause disease, potentially offering a one-and-done treatment for lupus.
• All patients stopped standard immunosuppressants post-treatment, with most significantly reducing steroid use, highlighting prula-cel's potential to replace current multi-drug regimens.
• The FDA has agreed to a pivotal single-arm trial for lupus nephritis starting next year, with plans to expand to broader lupus populations, positioning CAR-T therapies as a promising new frontier in autoimmune disease treatment.