Voice monitoring for side effects during CAR T-cell therapy
Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy
This project will test whether twice-daily smartphone voice recordings and brief daily neurologic checks can spot early neurologic side effects in adults receiving FDA-approved CAR T-cell therapy for non-Hodgkin lymphoma or multiple myeloma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | CAR-T, radiation, CAR T |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT07249528 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with pathologically confirmed non-Hodgkin lymphoma or multiple myeloma, ECOG ≤2, scheduled to receive an FDA-approved CAR T product, owning a smartphone, sufficiently fluent in English to perform structured voice tasks, and without significant pre-existing speech-impairing neurologic disorders.
Not a fit: Patients without a smartphone, insufficient English proficiency, or with pre-existing speech or severe neurologic disorders that impair speech are unlikely to be able to participate or benefit from this voice-based monitoring approach.
Why it matters
Potential benefit: If successful, this approach could allow earlier and easier detection of ICANS using simple smartphone voice tasks and brief neurologic checks, potentially enabling faster intervention and reducing complications.
How similar studies have performed: Early pilot work on voice and digital biomarkers has suggested promise for detecting neurologic changes, but using twice-daily smartphone voice recordings specifically for ICANS monitoring is relatively new and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — 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 (Consent Only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States (Recruiting)
- Weill Cornell Medical Center (Data Analysis Only) — New York, New York, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent Only) — Rockville Centre, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.