Saudi expert panel perspectives in addressing access barriers and defining eligible patient profiles for CAR T cell therapy in adult R/R B cell ALL

Relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) in adults is associated with poor prognosis and limited survival. This is despite advances in chemotherapy, targeted agents, and immunotherapy. CD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown high remission rates and durable responses in this patient setting. However, real-world implementation in Saudi Arabia remains inconsistent due to delays in referral, infrastructural limitations, and access issues. To develop practical, nationally relevant recommendations for patient selection and referral for CAR T-cell therapy in adult R/R B-ALL within the Saudi healthcare context. A national panel of nine hematology experts from major tertiary centers convened in May 2025. A structured pre-meeting questionnaire assessed institutional practices, eligibility criteria, toxicity management, and access barriers. Using a modified qualitative consensus approach, panelists reviewed available evidence and real-world experience to formulate pragmatic recommendations. The panel identified patient populations most likely to benefit from CAR T-cell therapy, including those refractory to induction or relapsed after ≥ 2 lines of therapy, post-transplant relapse (> 100 days), persistent measurable residual disease after blinatumomab, and high-risk molecular subgroups (e.g., KMT2A-rearranged and TP53-mutated disease). Product-specific recommendations were developed for brexucabtagene autoleucel, tisagenlecleucel, and obecabtagene autoleucel. Early referral, particularly in central nervous system involvement and “gray zone” transplant-ineligible patients, was emphasized. Key systemic barriers included late referral, lack of standardized pathways, geographic disparities, limited ICU capacity, diagnostic delays, and absence of a national registry. CAR T-cell therapy represents a transformative treatment modality for adult R/R B-ALL. A coordinated national strategy incorporating early referral triggers, standardized pathways, infrastructure expansion, and a centralized registry is essential to optimize equitable access and improve outcomes in Saudi Arabia.