Navigating Autoimmune Disease A Playbook For Cell And Gene Therapies

By Erin Finot, Jessica Knight-Perry, and Emily Smith

Cell and gene therapies (CAGT) are reshaping the treatment landscape for autoimmune diseases, offering new hope for patients whose conditions have long defied conventional care. As the industry shifts its focus from oncology to autoimmune indications, sponsors face unique challenges in translating scientific promise into patient benefit. Success depends on strategies that balance scientific rigor with patient-centered design.

Unlike oncology centers, autoimmune trial sites often require new infrastructure, cross-specialty collaboration, and extensive training to manage complex therapies. Patient engagement is equally critical: autoimmune patients, living with chronic conditions, weigh risks and benefits differently than those in oncology. Addressing concerns through clear communication, logistical support, and flexible participation options can strengthen recruitment and retention. Operationally, the demands of personalized treatments require meticulous planning and standardized protocols to protect both product integrity and patient safety.

By integrating site readiness, patient engagement, and data-driven decision-making, the CAGT field is advancing toward therapies that not only control disease but transform lives. The promise for autoimmune patients has never been greater.