Immune Effector Cell Resource Center

Notable Publications

Building a Program

• A Robust Quality Infrastructure is Key to Safe and Effective Delivery of Immune Effector Cells – How “FACT”-Finding Can Help
  Curran, KJ, et. al. (2023). doi: 10.1182/bloodadvances.2023010401
• Driving the CAR to the Bone Marrow Transplant Program
  Hema Dave, Jerkins, L., et al. (2019). doi: 10.1007/s11899-019-00544-6
• American Society for Blood and Marrow Transplantation Pharmacy Special Interest Group Survey on Chimeric Antigen Receptor T Cell Therapy Administrative, Logistic, and Toxicity Management Practices in the United States
  Mahmoudjafari, Z, Haws, KG, et al. (2019). doi: 10.1016/j.bbmt.2018.09.024
• Building a CAR Garage: Preparing for the Delivery of Commercial CAR T Products at Memorial Sloan Kettering Cancer Center
  Perica, K., et al. (2018). doi: 10.1016/j.bbmt.2018.02.018
• The Why, What, and How of the New FACT Standards for Immune Effector Cells
  Maus, MV & Nikiforow, S. (2017). doi: 10.1186/s40425-017-0239-0

Harmonizing Cellular Therapy Systems

• The Cell and Gene Therapy Consortium's Perspective on Harmonizing Data Collection for Patient Enrollment, Therapy Ordering and Scheduling, and Cell Collection
  Mora, A, et. al. (2023). doi: 10.1016/j.jtct.2023.08.011
• Paving the Road for Chimeric Antigen Receptor T Cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force Consensus on Challenges and Solutions to Improving Efficiency of Clinical Center Certification and Maintenance of Operations for Commercially Approved Immune Effector Cell Therapies
  Nikiforow, S, et. al. (2023). doi: 10.1016/j.jtct.2023.01.021

Establishing Guidelines

• Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome
  Hines, MR, et. al. (2023). doi: 10.1016/j.jtct.2023.03.006
• Introduction to How I Treat Series on Emergent CAR T-Cell Toxicities
  Heslop, HE. (2023). doi: 10.1182/blood.2023020228
• How I Treat Refractory CRS and ICANS After CAR T-Cell Therapy
  Jain MD, et. al. (2023). doi: 10.1182/blood.2022017414
• How I Treat Cytopenias After CAR T-Cell Therapy
  Jain T, et. al. (2023). doi: 10.1182/blood.2022017415
• How I Treat Unique and Difficult-to-Manage Cases of CAR T-Cell Therapy-Associated Neurotoxicity
  Santomasso BD, et. al. (2023). doi: 10.1182/blood.2022017604
• How I Approach Optimization of Patients at Risk of Cardiac and Pulmonary Complications After CAR T-Cell Therapy
  Gutierrez C, et. al. (2023). doi: 10.1182/blood.2022017579
• Immune Effector Cell-Associated Hematotoxicity: EHA/EBMT Consensus Grading and Best Practice Recommendations
  Rejeski, K, et. al. (2023). doi: 10.1182/blood.2023020578
• ASBMT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells
  Lee, DW, et al. (2018). doi: 10.1016/j.bbmt.2018.12.758
• Chimeric Antigen Receptor T-cell Therapy – Assessment and Management of Toxicities
  Neelapu, SS. (2017). doi: 10.1038/nrclinonc.2017.148
• Building a Safer and Faster CAR: Seatbelts, Airbags and CRISPR
  Perales, MA, et al. (2017). doi: 10.1016/j.bbmt.2017.10.017

Collecting Cells for Further Manufacturing

• A guide to the collection of T-cells by apheresis for ATMP manufacturing—recommendations of the GoCART coalition apheresis working group
  Worel, N, et. al. (2023). doi: 10.1038/s41409-023-01957-x
• Optimizing leukapheresis product yield and purity for blood cell-based gene and immune effector cell therapy
  Shi, PA. (2020). doi: 10.1097/MOH.0000000000000611

Manufacturing Immune Effector Cells

• Production of Chimeric Antigen Receptor T Cells
  Fesnak, AD, et. al. (2017). Nature America, Inc., part of Springer Nature.

Educational Resources  

Frequently Asked Questions:  Standards for Immune Effector Cells 

Selected On-Demand FACT Education 

• Tumor Infiltrating Lymphocytes
  Parameswaran, P & Mullinax, J. (2023).
• CAR-T Cells and T-Cell Receptor Cells in Solid Tumors
  Frigault, M & Kebriaei, P. (2023).
• FACT Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors: General Concepts and Need for Harmonization of Standards
  William, B & Nikiforow, S. (2022).
• Integration of Immune Effector Cellular Therapy Into a FACT Accredited Transplant Program
  Bachier, C. (2020).
• Bringing a Stand-Alone Immune Effector Cellular Therapy Program into FACT Compliance
  Shpall, EJ, et. al. (2020).

Examples

These documents are only examples of implementing aspects of an IEC program and are not required by FACT.

• Patient IEC Education
• Clinician IEC Management Education
• Clinical Guidelines for IEC Toxicity
• Chain of Custody Form
• Verification of Identity Form