NCT07249528Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 17 Apr 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Multiple myeloma
- NCT number
- NCT07249528
What you commit to
- Study type: Observational
- Planned participants: 20
- From 17 Apr 2026 to the primary completion date, Dec 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Consent Only) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (Consent Only) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Weill Cornell Medical Center (Data Analysis Only) Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Rockville Centre | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.