Recruiting

CAR T-Cell Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07249528

Conditions

Non-hodgkin Lymphoma

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Audio Tasks

Study Details

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.

Conditions

Non-hodgkin Lymphoma

Multiple Myeloma

Study ID

NCT07249528

Start date

Apr 17, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma

Participants must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.

Interventions

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

Primary outcome measure

  • Number of daily voice recordings collected [ Time Frame: 30 days after baseline ]
  • Number of neurocognitive assessments collected [ Time Frame: 30 days after baseline ]

Central Contacts and Locations

Central contacts

Roni Shouval, MD, PhD

646-888-3483shouvalr@mskcc.org

Mohammad Alhomoud, MD

646-608-4375alhomom@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Roni Shoulval, MD, PhD

646-888-3483

Memorial Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Roni Shouval, MD, PhD

646-888-3483

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Roni Shouval, MD, PhD

646-888-3483

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Roni Shouval, MD, PhD

646-888-3483

Memorial Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Roni Shouval, MD, PhD

646-888-3483

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Roni Shouval, MD, PhD

646-888-3483

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Roni Shouval, MD, PhD

646-888-3483

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Non-hodgkin Lymphoma
  • Multiple Myeloma
  • Memorial Sloan Kettering Cancer Center
  • 25-317

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-06.