CAR-T Therapy's hidden toll on the brain: new study investigates
NCT ID NCT04107285
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 120 adults with lymphoma who are receiving CAR-T cell therapy. Researchers will test memory, attention, and other thinking skills, and perform brain MRIs and blood tests before and after treatment. The goal is to understand how CAR-T therapy may affect the brain and cognition over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors predict and manage cognitive side effects of CAR-T therapy, improving patient quality of life.
- What could go wrong
- This is an observational study, not testing a new treatment. It may not lead to direct changes in care, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2019
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Can a calming drug make cord blood transplants safer?
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Do social factors decide who completes lymphoma treatment?
- Smartphone app and wearable sensor team up to catch infections early in cancer care