NCT07249528 A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy
| NCT ID | NCT07249528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Non-hodgkin Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-04-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Roni Shouval, MD, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07249528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07249528 currently recruiting?
Yes, NCT07249528 is actively recruiting participants. Contact the research team at shouvalr@mskcc.org for enrollment information.
Where is the NCT07249528 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 4 additional locations.
Who is sponsoring the NCT07249528 clinical trial?
NCT07249528 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Roni Shouval, MD, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 20 participants.