Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Audio Tasks | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma
- description
- Participants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.
- interventionNames
- Diagnostic Test: Audio Tasks
Primary outcomes (2)
- measure
- Number of daily voice recordings collected
- timeFrame
- 30 days after baseline
- description
- 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.
- measure
- Number of neurocognitive assessments collected
- timeFrame
- 30 days after baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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