Voice monitoring for side effects during CAR T-cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will use a smartphone app to record structured voice tasks twice daily and complete brief daily neurologic assessments (for example ICE score and tremor checks) while receiving standard-of-care CAR T-cell products. The study will collect these audio recordings alongside routine clinical data to determine whether voice changes correspond with immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility is the primary outcome and will be measured by enrollment rates and completion of the scheduled recordings and assessments. The protocol requires adult patients with pathologically confirmed non-Hodgkin lymphoma or multiple myeloma who are scheduled to receive an FDA-approved CAR T product and who can comply with the recording schedule.

Why it matters

Who can join: the full rules

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.

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Roni Shouval, MD, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Roni Shouval, MD, PhD
• Email: shouvalr@mskcc.org
• Phone: 646-888-3483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.