NCT07249528

A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy

Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect voice recordings and nervous system (neurologic) assessments from people with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) who are receiving standard treatment with CAR T-cell therapy. Researchers will study whether these voice recordings and assessments are a practical (feasible) way to monitor for immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility will be measured by tracking how many participants join the study and complete the assessments.

Conditions

• Non-hodgkin Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Audio Tasks	Voice recordings will be collected at baseline (pre-infusion), twice daily from Day 0 through Day +10, and, if ICANS develops, twice daily until three days after clinical resolution. A final voice recording will also be performed on Day +30

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-11-25
• Last updated: 2026-04-15

Locations

8 sites across 1 country: United States