TRK-001

TRK-001 is an autologous, polyclonally expanded regulatory T-cell (Treg) therapy developed by Singulera Therapeutics (formerly TRACT Therapeutics). The therapy is produced by isolating a patient's own Tregs through leukapheresis, expanding them in a laboratory setting, and re-administering them as a single intravenous infusion. TRK-001 is designed to establish immunological tolerance in recipients of solid organ transplants, particularly those receiving living donor kidney transplants. By enhancing the suppressive Treg population, the treatment aims to prevent graft rejection and reduce the long-term dependency on standard immunosuppressive medications, which are often associated with significant toxicity. TRK-001 has received Orphan Drug Designation for the prevention of graft rejection and is currently being investigated in the Phase 2 RETIRE clinical trial.

Other names

Autologous expanded regulatory T cellsTreg Adoptive Cell TransferTRACT therapy