cGMP-Grade Alloantigen-Specific Regulatory T Cells For Cell Therapy In Transplantation

Technology Description

UCSF investigators have developed a cGMP-compliant method to efficiently produce alloantigen-reactive regulatory T cells (arTregs) ex vivo for selective immune suppression. The method utilizes isolated patient regulatory T cells (Tregs) that are stimulated by and expanded in the presence of allogeneic B cells. The arTregs may be used to prevent or treat rejection of transplanted cells and organs, and to prevent or treat graft-versus-host disease (GvHD). The method is highly robust, and is one of the first cGMP-compliant approaches to efficiently expanding arTregs. 

Advantages

• cGMP-compliant process already reduced to practice
• Antigen-reactive Tregs are more specific for transplanted tissue than polyclonal Tregs, resulting in improved efficacy and safety
• Capable of up to 1600 fold expansion of Tregs 

State Of Development

The method has been used to produce arTregs under GMP for several phase 1 trials of kidney and liver transplantation, and the therapy is well tolerated.  A phase 2 study in liver transplantation will be initiated in 2020.

Related Materials

• Clinical Grade Manufacturing of Human Alloantigen-Reactive Regulatory T Cells for Use in Transplantation
• Issued Patent - US9801911B2

Patent Status