Clinical epidemiology · 2026
Real-World Incidence and Management of Non-Immune Effector Cell-Associated Neurotoxicity Syndrome Neurologic Events Following Ciltacabtagene Autoleucel in Multiple Myeloma.
СтатьяНазвание и аннотация: Перевод в очереди
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Hansen Doris K, Castaneda Puglianini Omar Alexis, Grajales-Cruz Ariel, Nagar Saurabh P, Ghosh Sabyasachi, Alegria Victoria, De Braganca Kevin C, Lengil Tamar, Sharma Mukta, Pai Helen, Perciavalle Matthew, Maitland Jessica, Emond Bruno, Bixby Todd, Qureshi Zaina P, Janakiram Murali
Аннотация
PURPOSE: Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell (CAR-T) therapy for relapsed/refractory multiple myeloma (RRMM) approved after 1 prior line of therapy (LOT). Non-immune effector cell-associated neurotoxicity syndrome (ICANS) neurologic events (NEs) may occur following infusion. This real-world study evaluated non-ICANS NE onset and management among patients with RRMM treated with cilta-cel.
PATIENTS AND METHODS: Electronic medical records from Loopback Analytics (02/2022-05/2025) were used, supplemented with physician notes. Adults treated with cilta-cel after 1-3 and ≥4 prior LOT were included (N=171). New-onset non-ICANS NEs included cranial nerve palsy (CNP), parkinsonism, and Guillain-Barré syndrome. Clinical outcomes among these patients were described.
RESULTS: Among 171 patients, 73 had 1-3 prior LOT and 98 had ≥4 prior LOT. Among patients with 1-3 prior LOT (median follow-up: 6.1 months), CNP occurred in 4 patients, while no parkinsonism or Guillain-Barré syndrome were observed. Following CNP onset, symptoms improved among 3 patients. Among patients with ≥4 prior LOT (median follow-up: 17.4 months), CNP occurred in 3 patients, while parkinsonism and Guillain-Barré syndrome each occurred in 1 patient. All patients with CNP had symptom improvement and the patient with Guillain-Barré syndrome had symptom resolution. Median peak ALC (103 cells/µL) was higher in patients with versus without non-ICANS NEs (1-3 prior LOT: 7.60 vs 2.12; ≥4 prior LOT: 11.64 vs 1.96). All patients with events had at least a partial response to cilta-cel and remained alive at the end of follow-up.
CONCLUSION: This real-world cohort showed low incidence of CNP, parkinsonism, and Guillain-Barré syndrome following cilta-cel. Elevated post-infusion ALC warrants further investigation into its role as a biomarker to inform monitoring and management strategies, consistent with prior reports. Most patients with CNP reported improvement, the patient with Guillain-Barré syndrome reported resolution, all patients with available response assessments responded to cilta-cel, and no deaths were reported.
PATIENTS AND METHODS: Electronic medical records from Loopback Analytics (02/2022-05/2025) were used, supplemented with physician notes. Adults treated with cilta-cel after 1-3 and ≥4 prior LOT were included (N=171). New-onset non-ICANS NEs included cranial nerve palsy (CNP), parkinsonism, and Guillain-Barré syndrome. Clinical outcomes among these patients were described.
RESULTS: Among 171 patients, 73 had 1-3 prior LOT and 98 had ≥4 prior LOT. Among patients with 1-3 prior LOT (median follow-up: 6.1 months), CNP occurred in 4 patients, while no parkinsonism or Guillain-Barré syndrome were observed. Following CNP onset, symptoms improved among 3 patients. Among patients with ≥4 prior LOT (median follow-up: 17.4 months), CNP occurred in 3 patients, while parkinsonism and Guillain-Barré syndrome each occurred in 1 patient. All patients with CNP had symptom improvement and the patient with Guillain-Barré syndrome had symptom resolution. Median peak ALC (103 cells/µL) was higher in patients with versus without non-ICANS NEs (1-3 prior LOT: 7.60 vs 2.12; ≥4 prior LOT: 11.64 vs 1.96). All patients with events had at least a partial response to cilta-cel and remained alive at the end of follow-up.
CONCLUSION: This real-world cohort showed low incidence of CNP, parkinsonism, and Guillain-Barré syndrome following cilta-cel. Elevated post-infusion ALC warrants further investigation into its role as a biomarker to inform monitoring and management strategies, consistent with prior reports. Most patients with CNP reported improvement, the patient with Guillain-Barré syndrome reported resolution, all patients with available response assessments responded to cilta-cel, and no deaths were reported.