Phase I Evaluation of Arlocabtagene Autoleucel in RRMM
Bal S, Htut M, Nadeem O, et al. Arlocabtagene Autoleucel-a GPRC5D-Targeted CAR T-Cell Therapy in Heavily Pretreated Relapsed/Refractory Multiple Myeloma. Blood Advances. 2026; (doi: 10.1182/blood.2025030750).
Researchers say promising Phase I evidence justifies advanced clinical trials to investigate the use of arlocabtagene autoleucel (arlo-cel) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). A single infusion of the autologous chimeric antigen receptor T-cell therapy was administered to 84 adults with RRMM enrolled in a dose-escalation/expansion study. Participants had previous treatment exposure to, at a minimum, an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody — although many had undergone ≥3 prior lines of therapy. Arlo-cel was effective in the study population, with an overall response rate of 87% and complete response rate of 53% at a median follow-up of 16.1 months. Median progression-free survival was 18.3 months, and 1-year overall survival reached 90%. Median duration of response was 18 months, underscoring the durability of arlo-cel. The safety profile was acceptable, with most toxicities were grade 1/2 and the on-target/off-tumor skin, nail, and oral adverse events were transient in nature.