Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07249528

A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-27

20

Participants Needed

8

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with non-Hodgkin lymphoma or multiple myeloma confirmed by pathology
  • 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 and daily neurologic assessments
  • Age 18 years or older
  • ECOG Performance Status of 0, 1, or 2
  • Ability to perform twice daily voice recordings using a smartphone
  • Willingness to undergo daily neurologic assessments such as ICE score and tremor evaluation
  • Ownership of a smartphone
  • Sufficient English proficiency to complete structured voice tasks in the study app
Not Eligible

You will not qualify if you...

  • Pre-existing neurological conditions that significantly impair speech, such as severe dysarthria, expressive aphasia, or neurodegenerative disorders
  • History of significant speech or voice disorders, including laryngeal paralysis, severe dysphonia, or recent vocal cord surgery or radiation
  • Vocal cord pathology affecting voice analysis, such as vocal cord paralysis, chronic laryngitis, nodules, polyps, granulomas, or malignancies
  • Severe hearing impairment interfering with voice assessments
  • Language barriers preventing reliable completion of voice tasks or data interpretation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States, 10604

Actively Recruiting

6

Weill Cornell Medical Center (Data Analysis Only)

New York, New York, United States, 10021

Not Yet Recruiting

7

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States, 10065

Actively Recruiting

8

Memorial Sloan Kettering Nassau (Consent Only)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

R

Roni Shouval, MD, PhD

CONTACT

M

Mohammad Alhomoud, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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