Developing and Monitoring a Standard-of-Care Chimeric Antigen Receptor (CAR) T Cell Clinical Quality and Regulatory...

Area of Science:

• Cellular Therapy
• Quality Management
• Regulatory Compliance

Background:

• The expansion of cellular therapies, including immune effector cell (IEC) products like chimeric antigen receptor (CAR) T cells, presents challenges for quality management (QM).
• Healthcare organizations must adapt existing hematopoietic cell transplantation (HCT) programs or create new ones to meet quality, regulatory, and accreditation standards for patient safety.

Purpose of the Study:

• To describe the process used by City of Hope (COH) to expand their HCT quality management program to encompass IEC therapies.
• To share insights on developing program structure, patient care management, and accreditation strategies for similar expansions.

Main Methods:

• Collaborative development of quality structure involving quality, regulatory, and CAR T patient care committees.
• Implementation of new regulatory infrastructure within an existing HCT program.
• Monitoring data collection and reporting, conducting quarterly audits, and measuring endpoints for benchmarking.

Main Results:

• Successful expansion of the HCT QM program to include IEC products.
• Established a robust quality structure through interdisciplinary collaboration.
• Maintained high-quality patient care while integrating new regulatory requirements.

Conclusions:

• Expanding existing HCT QM programs is a viable strategy for incorporating IEC therapies.
• QM professionals are crucial in guiding the implementation of accreditation requirements and managing their impact on patient care.
• The COH experience provides a model for other institutions seeking to develop or enhance their cellular therapy programs.