On November 8, 2026, CRISPR Therapeutics reported an update from its ongoing Phase 1 study of zugo-cel, an investigational CD19-targeting, gene-edited allogeneic CAR-T therapy for difficult-to-treat autoimmune diseases.
As of October 15, 21 patients had been treated:
four with systemic lupus erythematosus (SLE), eight with systemic sclerosis (SSc), and nine with idiopathic inflammatory myopathy (IIM).
In systemic sclerosis, 5 of 6 patients given standard lymphodepletion achieved an rCRISS-25 response at Month 3; two met the more stringent rCRISS-50 threshold. All five responders maintained their response at the reported follow-up.
All nine IIM patients achieved a moderate or major Total Improvement Score response. In SLE, 2 of 3 evaluable patients remained in drug-free DORIS remission through at least Month 9; one had exceeded a year.
The company reported no dose-limiting toxicities, cytokine release syndrome above Grade 2, ICANS, severe infections, GvHD, or deaths among the 21 patients treated to date.
These are early, small-cohort Phase 1 findings, not proof of effectiveness. The trial is ongoing, and the therapy remains investigational.
Sources:
Press Releases - CRISPR Therapeutics
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