Good manufacturing practice-grade cytotoxic T lymphocytes specific for latent membrane proteins (LMP)-1 and LMP2 for patients with Epstein–Barr virus-associated lymphoma

In the last decade, virus specific CTL manufacture has become a more widespread and reproducible technology. A number of clinical grade techniques have been described. Here we outline the approach used at Baylor College of Medicine (BCM) since 2004 to treat over 35 patients with EBV-positive lymphoma using T cells specific for the latent membrane proteins (LMP1 and LMP2) of EBV in phase I/II clinical trials. Clinical outcomes have been described, but briefly objective tumor responses were achieved in 11/16 patients and complete remissions in 8. [1], [2]Here we outline the CTL manufacturing process. We have made the detailed SOPs required available with appropriate URL links throughout the manuscript. These should facilitate the creation of protocols suitable for regulatory approval and provide the basis for GMP manufacture of LMP1- and LMP2-specific T cells.