More than half of lupus patients in Adicet Bio’s Phase 1 trial reached remission at 12 months. The company’s cell therapy, prulacabtagene leucel (prula-cel), also helped half of lupus nephritis patients achieve full kidney response. These results came without ongoing immunosuppressant drugs.
Prula-cel, formerly known as ADI-001, is a CD20-targeted allogeneic gamma delta CAR-T cell therapy developed for autoimmune diseases, with lupus nephritis and SLE as lead indications.
Safety did not take a back seat. Prula-cel was generally well tolerated. No patient had cytokine release syndrome above Grade 2. There were no cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome. No one developed Immune Effector Cell-Associated Neurotoxicity Syndrome. This is notable. The trial enrolled people with tough, high-risk disease who had already failed multiple drugs.
Adicet Bio announced on September 25, 2026, that it had completed the last patient visit for the planned Phase 1 safety and efficacy analysis of prula-cel in systemic lupus erythematosus, with or without lupus nephritis, and scheduled a webcast for September 28, 2026, to present the data.
Other cell therapies are also showing promise in autoimmune disease. Recent reports describe durable, drug-free remission in hard-to-treat cases. Competition is growing. Still, Adicet Bio’s results set a high bar for both safety and efficacy in lupus. This disease has long resisted lasting treatments.
Adicet Bio has already presented the data in a webcast. Pivotal trial planning is underway. The company is focusing on patients who did not respond to at least two immunosuppressants. The main target is complete kidney response at 12 months. If these results hold up in larger studies, prula-cel could change the standard for lupus care. It could also shift what is possible for cell therapy in autoimmune disease. More details are available at https://www.adicetbio.com.
Third-party market coverage shows that at least 13 of the 22 patients had 12 months of follow-up. The update was expected by the end of September 2026. Interest in cell therapies for tough autoimmune diseases is rising. The FDA has given prula-cel Fast Track status for relapsed or refractory class III or IV lupus nephritis, refractory SLE with extrarenal involvement, systemic sclerosis, and rheumatoid arthritis. This shows strong regulatory momentum for the program. For more, see the Investing.com market update.
