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
1 other identifier
interventional
20
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedStudy Start
First participant enrolled
April 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 27, 2026
April 1, 2026
1.6 years
November 18, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of daily voice recordings collected
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.
30 days after baseline
Number of neurocognitive assessments collected
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.
30 days after baseline
Study Arms (1)
Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma
EXPERIMENTALParticipants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Weill Cornell Medical Center (Data Analysis Only)
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roni Shouval, MD, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2025
First Posted
November 25, 2025
Study Start
April 17, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.