Standardization Of Car T-Cell Program Implementation In The Sarah Cannon Blood Cancer Network

The Sarah Cannon Blood Cancer Network (SCBCN) consists of hematopoietic cell transplant (HCT) programs, 6 in the US and 3 in the UK, performing more than 1,100 autologous and allogeneic transplants annually with standard quality systems, patient care and research protocols, training and competency assessment and contracting. SCBCN programs in the US have been deeply involved in CAR T-cell clinical trials for both blood cancer and solid tumor indications, enrolling more than 60 patients. Some network programs did not have direct experience with CAR T-Cell Therapy and all programs needed an infrastructure to address the complex clinical, administrative and regulatory issues associated with delivery of commercially available CAR T-cells outsides the confines of a clinical trial. In order to ensure consistency of care and appropriate team training as well as to optimize lessons learned across the teams, the SCBCN team developed a standardized approach for all clinical and operational aspects of clinical research and FDA-approved CAR T-Cell Therapy implementation. Objectives for a successful transition from clinical trials to FDA-approved therapy included: 1. Maintaining Patient Safety, 2. Maintaining Regulatory Compliance, and 3. Minimizing Financial Risk The following processes were established: 1. Organization of the multidisciplinary SCBCN Network Executive Committee 1. Local IECT Committee reports up through Network Committee 2. FACT IEC accreditation 3. Adoption of patient eligibility criteria 4. Quality metrics established 5. Capacity evaluation 2. Establishment of Regulatory Guidelines 1. REMS implementation and tracking 2. Network readiness assessment 3. Establishment of Administrative Process 1. Worked with vendors at a national level to ensure consistency and efficiencies 2. Business case required of each program 3. Electronic patient approval process 4. Reimbursement monitoring 5. Process maps developed by multidisciplinary teams 6. Template SOPs, forms, education u0026 training An IECT toolkit was developed containing: • Forms/documentation tools/order sets • Staff competency tools • Staff education materials • Patient education materials • Supporting documents • Coding guidance • Standardized chargemaster • Training slide decks • Mock walkthrough examples • Readiness checklist • Sample process maps • On-line education modules developed: ○ CAR T-Cell: A new Frontier (0.5 CNE) ○ CAR T-Cell: Toxicities (0.5 CE) Results To date, the 5 programs that have been approved by Sarah Cannon to move forward with CAR T-Cell Therapy Program Development have received certifications for FDA-approved CAR T-Cell products. CAR T-Cell clinical trials remain the first choice for all eligible patients. Network Readiness Assessments identified gaps in some programs that were mitigated by sharing resources developed by other SCBCN programs (e.g. process map examples).