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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07249528
Enrollment
20
Registered
2025-11-25
Start date
2026-04-17
Completion date
2027-12-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Non-hodgkin Lymphoma

Keywords

Non-hodgkin Lymphoma, Multiple Myeloma, Memorial Sloan Kettering Cancer Center, 25-317

Brief 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.

Interventions

DIAGNOSTIC_TESTAudio 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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Documentation of Disease o Patients must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma. * Definition of treatment and ability * Scheduled to receive an FDA-approved CAR-T product: Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel. * Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator. * Age ≥ 18 * ECOG Performance Status of ≤ 2 * Required * Perform twice daily voice recordings using a smartphone. * Undergo daily neurologic assessments (e.g., ICE score, tremor evaluation). * Smartphone ownership. * Sufficient English proficiency to complete structured voice tasks in the study application. * Comorbid Conditions * No pre-existing neurological conditions that significantly impair speech, including but not limited to severe dysarthria, expressive aphasia, or neurodegenerative disorders. * No history of significant speech or voice disorders, including laryngeal paralysis, severe dysphonia, or recent vocal cord surgery or radiation to the area. * No pathology affecting the vocal cords that could interfere with voice analysis, such as vocal cord paralysis, chronic laryngitis, vocal cord nodules, polyps, granulomas, or malignancies. * No severe hearing impairment that would interfere with voice assessments * Language o Proficiency in spoken English is required, without the need for native-level fluency. This ensures participants can accurately perform structured voice tasks, as the application and underlying acoustic models are currently validated only in English, despite the limitation in generalizability. Participants with language barriers that prevent reliabletask completion or data interpretation will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Number of daily voice recordings collected30 days after baselineTo prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy.
Number of neurocognitive assessments collected30 days after baselineTo prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy.

Countries

United States

Contacts

CONTACTRoni Shouval, MD, PhD
shouvalr@mskcc.org646-888-3483
CONTACTMohammad Alhomoud, MD
alhomom@mskcc.org646-608-4375
PRINCIPAL_INVESTIGATORRoni Shouval, MD, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026