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Does CAR-T therapy affect the brain? a study investigates

NCT ID NCT07740317

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study follows people with relapsed or refractory multiple myeloma who are scheduled to receive BCMA CAR-T therapy, a type of cell treatment. Researchers will test memory, attention, and other thinking skills at the start and again at 1, 6, and 12 months after the infusion. The goal is to see if any cognitive changes occur over time and how common they might be.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Standardized neurocognitive testing (cognitive assessments at baseline and at 1, 6, and 12 months after CAR-T infusion)
What this could lead to
If this trial succeeds, it could reveal whether CAR-T therapy affects thinking and memory in myeloma patients, guiding future monitoring and support.
What could go wrong
This is an observational study with a small group (50 people), so results may not apply to everyone. Also, cognitive changes could be due to the disease or other treatments, not just CAR-T.

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 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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

Patients who have been scheduled to receive BCMA CAR-T therapy as their next line of therapy will be identified and approached for consent.

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ability to understand and willingness to sign an IRB-approved informed consent 2. Ability to retain independent decision-making capacity as per the enrolling investigator 3. Age ≥ 18 years of age at the time of consent 4. Scheduled to receive BCMA CAR-T therapy for RRMM as confirmed by the treating clinician 5. Ability to read and understand the English language 6. ECOG 0-2 7. If actively taking benzodiazepine, must be able to hold for 3 hours prior to study assessments as per treating clinician 8. Reliable access to internet access; a tablet, laptop and/or desktop computer with a camera; or willingness to come into the clinic to conduct study procedures as outlined in the Study Calendar- as per participant self-report 9. Ability to complete required assessments, as determined by the treating clinician Exclusion Criteria: 1. Active central nervous system (CNS) disease 2. Known neurodegenerative disease or major neurocognitive disorder 3. Stroke and/or traumatic brain injury (TBI) within 12 months 4. Concurrent investigational neuroactive drugs

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Atrium Health Levine Cancer

    Charlotte, North Carolina, 28204, United States

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