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NCT Number: NCT07249528

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Audio Tasks

Diagnostic Test

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

Primary outcomes

  1. Number of daily voice recordings collected

    Time frame: 30 days after baseline

    To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy.

  2. Number of neurocognitive assessments collected

    Time frame: 30 days after baseline

    To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Alhomoud, MD

CONTACT

[email protected]

646-608-4375

Roni Shouval, MD, PhD

CONTACT

[email protected]

646-888-3483

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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