UC San Diego Health San Diego, California, United States
Background/Case Studies: Prior to 2017, the primary workload of many cellular therapy laboratories consisted of standard of care (SOC) bone marrow transplant (BMT) utilizing minimally manipulated hematopoietic progenitor cells (HPCs). Chimeric antigen receptor T-Cell (CAR-T) therapies became commercially available in 2017 and presented a new, fundamentally different SOC cellular therapy. In contrast to HPCs, commercial CAR-T products consist mostly of CD3+ cells, have different apheresis collection procedures, are manufactured off-site, and follow vendor-specific dosing guidelines and infusion procedures.
Our academic health system includes a 364-bed tertiary care hospital that houses a BMT program, which infused its first commercial CAR-T products in 2018. We sought to examine the changing rates of HPC and CAR-T use at our center and describe the associated adjustments to staffing, internal processes, and documents necessary to support the growth of CAR-T therapies.
Study
Design/Methods: We retrospectively reviewed and quantitated annual HPC and CAR-T collections and infusions from 2017-2024. We also compiled changes to laboratory staffing, standard operating procedures (SOPs), training methods, forms, and communications related to CAR-T products.
Results/Findings: From 2017-2024, annual HPC collections and infusions ranged from 230 (2017) to 357 (2020), and 187 (2021) to 256 (2018), respectively. Annual CAR-T collections and infusions ranged from 0 (2017) to 97 (2024), and 0 (2017) to 86 (2024), respectively. During the study period, HPCs annually averaged +3.4% change in collections and -1.5% in infusions, while CAR-Ts annually averaged +88.3% change in collections and +93.2% in infusions. Overall, HPC collections/infusions trended down while CAR-T collections/infusions increased (Figure 1).
CAR-Ts necessitated numerous programmatic changes. Since 2017, the BMT team added 6.6 CAR-T-related staff to support different sectors. A multidisciplinary team established biweekly meetings, developed a procedure for the lab to notify coordinators of product receipt, and created a new electronic infusion order for CAR-T products. To meet the quality standards for each CAR-T, new documents were created including 9 SOPs, 1 physician’s order, and 1 infusion record. New laboratory staff training modules, specific for up to 6 individual CAR-T products, included annual risk evaluation and mitigation (6), shipping of starting material (4), and product delivery (6).
Conclusions: Our BMT program executed changes to staffing, processes, and communications to accommodate the addition of CAR-Ts as SOC. In the laboratory, numerous SOPs, forms, and training methods required changes, compelling significant investments in time and staff resources. Provision of CAR-Ts continues to require growth and adaptation.
