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

Tech ID: 32024 / UC Case 2011-138-3

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

Patent Status

Country Type Number Dated Case
United States Of America Published Application 20180036345 02/08/2018 2011-138
 

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Keywords

arTreg, alloantigen-reactive regulatory T cells, transplantation, graft-versus-host disease

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