Recruiting

CAR-T Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04107285

Conditions

Lymphoma Receiving CAR-T Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

neurocognitive evaluations

brain MRIs

Blood samples

Study Details

Brief summary:

The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.

Conditions

Lymphoma Receiving CAR-T Therapy

Study ID

NCT04107285

Start date

Sep 25, 2019

Status verified date

Oct, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
  • Patients must have adequate end organ function for CAR T cell therapy

  • Eastern Cooperative Group (ECOG) performance status of 0 to 2
  • Meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for CART therapy as described in corresponding product package insert
  • No evidence of central nervous system disease at study entry
  • Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional. o Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required

Exclusion Criteria:

  • Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
  • Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
  • History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report
  • A history of epilepsy as per medical records or patient report
  • Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report
  • Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
  • Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Neurocognitive evaluation prior to and following CART

Interventions

neurocognitive evaluations

The test battery consists of validated and reliable measures of attention, executive functions and memory.

brain MRIs

Patients will undergo baseline and follow-up research MRIs in the same scanner at MSKCC (3 Tesla scanner (GE, Discovery 750W, USA) with a GEM HNU 24-channel head coil) (total scan duration=15 minutes).

Blood samples

Research blood samples will be collected pre-CAR T infusion; day of CART infusion (day 0), and post-infusion days 7, 14, 21, 28 (+/- 7 days), at start of neurotoxicity, and at 3-4 months and 6-7 months post-CART.

Primary outcome measure

  • changes in neurocognitive functions [ Time Frame: 1 year ]
  • changes in functional connectivity [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Bianca Santomasso, MD, PhD

646-888-2092santomab@mskcc.org

Denise Correa, PhD

212-610-0487

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Bianca Santomasso, MD, PhD

646-888-2092

Dennis Correa, PhD

212-610-0487

Principal Investigator:

Bianca Santomasso, MD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • Neurocognitive Evaluations
  • Neuroimaging Evaluations
  • 19-268

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 2025-10-24.