Utilizing a patient’s immune system to combat cancer is a hot topic in research and in translational medicine, with several therapies now commercially available for use. In 2017, FACT published standards and implemented an accreditation program for immune effector cells (IECs), defined as, “A cell that has differentiated into a form capable of modulating or effecting a specific immune response.”1 This definition includes, but is not limited to, cell-based therapies such as chimeric antigen receptor (CAR) T cells, tumor infiltrating lymphocytes (TILs), T cell receptor (TCR)-modified T cells, therapeutic vaccines, and NK- or B-cell based therapies. Activities related to IECs that are performed at FACT-accredited cellular therapy programs must comply with FACT Standards.
But what about BiTEs? Bispecific T cell engagers are emerging as an efficacious therapy that leads T cells to fight tumor cells.2 FACT-accredited programs are increasingly using them in their own programs but also see oncologists in other institutional departments or in other practices prescribing them. They have an immunological mechanism of action, but they are antibodies rather than a cell-based therapy. Therefore, they are not specifically eligible for FACT accreditation or required to be administered by an accredited program.
When handled on a FACT-accredited unit, BiTEs should be treated like any other drug or antibody: utilizing standard operating procedures, personnel trained to administer them and recognize toxicities, confirmation of correct patient and drug, etc. BiTEs do have toxicities similar to CAR-T cells, such as cytokine release syndrome. When administered by medical staff not affiliated with a FACT-accredited IEC or transplant team, it may be useful for the IEC or transplant team to assist as needed with toxicity management, but this is not required.
Because BiTEs have similar toxicities, experience with them may prepare nurses and other staff with management of CAR-T patients in the future. Utilizing BiTEes experience may assist programs preparing to onboard and seek accreditation for IECs.
1 Foundation for the Accreditation of Cellular Therapy and Joint Accreditation Committee – ISCT and EBMT. FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (Eighth Edition); 2021.
2 Tian, Z., Liu, M., Zhang, Y. et al. Bispecific T cell engagers: an emerging therapy for management of hematologic malignancies. J Hematol Oncol 14, 75 (2021). https://doi.org/10.1186/s13045-021-01084-4.