Kyverna Therapeutics, a clinical-stage biopharmaceutical company headquartered in Emeryville, California, has signed a manufacturing agreement with Waltham, Massachusetts-based contract development and manufacturing organization (CDMO) ElevateBio to provide U.S. commercial and global clinical supply of mivocabtagene autoleucel (miv-cel), the company’s investigational autologous CD19-directed CAR T-cell therapy.

Under the agreement, ElevateBio will provide scalable manufacturing capacity to support potential commercial launches of miv-cel for stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), as well as ongoing clinical development programs. The collaboration continues a three-year manufacturing partnership focused on process development, quality systems, and manufacturing optimization.

Kyverna said the manufacturing agreement supports its commercialization strategy as it prepares to complete a rolling Biologics License Application (BLA) submission for miv-cel in SPS during the fourth quarter of 2026. If approved, the therapy could become the first FDA-approved CAR T-cell therapy for an autoimmune disease and the first approved treatment for SPS.

According to the company, ElevateBio has achieved a clinical manufacturing success rate of more than 98% for miv-cel production. The manufacturing platform is intended to support future commercial demand while maintaining manufacturing consistency as the therapy advances toward potential regulatory approval.

The announcement follows continued investment by ElevateBio in expanding cell and gene therapy manufacturing capacity. Earlier this year, the company highlighted construction of its 125,000-square-foot BaseCamp Pittsburgh facility, which is expected to open in 2027 and incorporate automation, digital manufacturing technologies, and end-to-end cGMP capabilities to support large-scale production of advanced therapies.