Roche Initiates Phase I Clinical Trial of Allogeneic CD19/CD20 CAR-T Therapy P-CD19CD20-ALLO1 in Severe Refractory Systemic Lupus Erythematosus

▎Armstrong

On May 22, 2025, Roche registered a Phase I clinical trial on the Clinicaltrials.gov website for the treatment of severe relapsing systemic lupus erythematosus with a universal CD19/CD20 CAR-T therapy.

This Phase I clinical trial plans to enroll 162 patients with severe systemic lupus erythematosus and is expected to be completed by 2033.

The inclusion criteria were failure of two treatment regimens in the past 3 months, SLEDAI-2K score ≥8, urine protein-to-creatinine ratio >1g/g, etc.

P-CD19CD20-ALLO1 is one of the core pipelines of Poseida Therapeutics. In November 2024, Roche acquired Poseida Therapeutics for $1 billion in cash and $500 million in milestone payments.

Poseida's universal CAR-T therapy technology platform has a series of differentiated design advantages.

Poseida's universal BCMA CAR-T therapy has demonstrated excellent efficacy potential, including in patients resistant to BCMA-targeted treatments.

Summary

Focusing on B-cell depletion, Roche has multiple CD antibodies and TCE products approved for marketing. The subsequent iterations have shifted the focus to universal CAR-T therapies, rapidly expanding from hematologic malignancies to solid tumors and autoimmune indications.