Varnimcabtagene Autoleucel (ARI-0001) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and Richter Transformation (RT)

Background: The prognosis of CLL patients that do not respond to targeted therapy is unfavourable, especially in the case of adverse genomic aberrations (e.g. TP53 alterations or complex karyotype) or after transformation to aggressive B lymphoma (Richter transformation, RT). In patients with refractory CLL, anti-CD19 CAR-T (CART19) therapy has achieved complete response (CR) rates of 19-45%, with RT usually excluded from pivotal trials. However, long-term remission in CLL patients still remains a challenge with CART19 therapy.