Delay in CAR-T from Single Case Agreements: Real-World Impact on Treatment & Outcomes in at least Twice-Refractory DLBCL Open Access

1. Patients requiring a single case agreement experienced a significantly longer Brain-to-Vein time compared to those who did not.

2. There were no statistically significant differences in treatment outcomes between those requiring or not requiring a single case agreement.

Chimeric antigen receptor T-cell (CAR-T) is an effective treatment for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Delays before apheresis, particularly due to the need for a single-case agreement (SCA) between treatment centers and insurers, can impact timely access to care. We performed a single-center retrospective study of 65 patients with at least twice treated DLBCL who intended to receive commercial CAR-T therapy between 2018–2022. Patients were stratified by SCA requirement. The pre-infusion timeline was divided into Brain-to-Vein (B2V; intent to apheresis) and Vein-to-Vein (V2V; apheresis to infusion) periods. Outcomes included complete response (CR), progression-free survival (PFS), overall survival (OS), and Cellular Therapy Intent Quotient (CTIQ, defined as the fraction of patients infused among those intending CAR-T). Forty-four (68%) required a SCA. Median B2V time was significantly longer in the SCA group (33 vs. 17 days, p<0.0001). V2V times were similar. No significant differences were observed in CR (46% vs. 57%, p=0.42), PFS (7.33 vs. 16.56 months, p=0.22), OS (15.34 vs. 44.62 months, p=0.10), or CTIQ (88.6% vs 100%, p=0.17) for the SCA and non-SCA groups, respectively. SCAs contribute to delays in CAR-T initiation without significantly affecting outcomes. Streamlining pre-apheresis processes may help improve timely access to CAR-T.