A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy
NCT ID: NCT07249528
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2026-02-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma
Participants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.
Audio Tasks
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
Interventions
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Audio Tasks
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
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Roni Shouval, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Weill Cornell Medical Center (Data Analysis Only)
New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Roni Shoulval, MD, PhD
Role: primary
Roni Shouval, MD, PhD
Role: primary
Roni Shouval, MD, PhD
Role: primary
Roni Shouval, MD, PhD
Role: primary
Roni Shouval, MD, PhD
Role: primary
Roni Shouval, MD, PhD
Role: primary
Roni Shouval, MD, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-317
Identifier Type: -
Identifier Source: org_study_id
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