Treatment with arlocabtagene autoleucel (arlo-cel), a chimeric antigen receptor T-cell therapy targeting G protein-coupled receptor class C group 5 member D (GPRC5D), yielded deep and durable responses in patients with relapsed or refractory multiple myeloma, according to a presentation at the Fourteenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2026) in Houston, Texas.
Final results from the first-in-human phase 1 study of arlo-cel represent the longest follow-up with GPRC5D CAR T-cell therapy in relapsed or refractory multiple myeloma, and continue to demonstrate deep, durable responses following a single arlo-cel infusion, wrote the study’s authors, led by Susan Bal, MD, of University of Alabama at Birmingham.
The trial enrolled patients with relapsed or refractory multiple myeloma after three or more prior lines of treatment including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody. The final analysis presented at SOHO 2026 described outcomes in patients who received one of two arlo-cel dose levels being evaluated in pivotal trials, either 75×106 or 150×106 CAR T-cells.
Out of 86 enrolled patients, 84 received arlo-cel infusion, of which 24 received the 75×106 dose level and 26 received the 150×106 dose level. Between the two dose groups, 42% and 50% of patients had high-risk cytogenetics, respectively. Both groups had a median of five prior lines of therapy.
Overall, 75% of the 75×106 dose group and 69% of the 150×106 dose group had treatment-related grade 3 or 4 adverse events (AEs). Grade 1 or 2 cytokine release syndrome occurred in 75% and 88% of patients, respectively, and grade 1 or 2 immune effector cell-associated neurotoxicity syndrome occurred in one patient in each group. Other select neurotoxicities occurred in three patients in the 150×106 dose group and none in the 75×106 dose group. Rates of GPRC5D–related nail, skin, and oral AEs were similar between the two dose groups, according to the authors.
Among patients evaluable for efficacy, the median follow-up was 24.2 months (range, 3.8-38.4) in the 75×106 dose group and 24 months (range, 4.6-36) in the 150×106 dose group. The overall response rates were 92% and 91% and complete response rates were 58% and 43%, respectively. The median duration of response was 16.4 months (95% CI, 11.1-23.4) in the 75×106 dose group and 13.6 months (95% CI, 5.3-not available) in the 150×106 dose group.
Findings support arlo-cel as a safe and effective potential late-line treatment option in relapsed or refractory multiple myeloma, Dr. Bal and colleagues wrote.
Reference
Bal S, Htut M, Nadeem O, et al. Arlocabtagene autoleucel in patients with heavily pretreated relapsed/refractory multiple myeloma: final analysis from the phase 1 study. Abstract MM-1119. Presented at the 2026 Society of Hematologic Oncology Annual Meeting; September 9-12, 2026; Houston.
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