Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond

Starting soon

Conditions studied: CAR T Cell Therapy, ICANS, Cognitive and Executive Dysfunction

In brief

This is a phase 4 non-interventional single center trial. We aim to prospectively include patients scheduled to undergo CAR-T therapy at ME CAST, Karolinska University Hospital Huddinge, to study ICANS. Because ICANS develops rapidly, inclusion during this potentially life-threatening phase would not be feasible; patients must therefore be enrolled before they start treatment. We aim to include patients who are clinically at high risk of developing ICANS. The risk of ICANS is assessed based on diagnosis, tumor burden, CAR-T product, and inflammatory status prior to treatment initiation. We plan to compare patients who develop ICANS grade 2-4 with patients who develop no ICANS or at most grade 1. Patients will undergo Positron Emission Tomography (PET) with two different tracers: (1) PBR28 for TSPO, which provides a measure of brain inflammation-this ligand binds to microglial cells-and (2) 11C-UCB-J for SV2A, which provides a measure of synaptic density in the brain. The results will be compared with magnetic resonance imaging. We will collect blood, bone marrow and cerebrospinal fluid (CSF) samples from this patient cohort. Samples will be taken from all patients before, during, and after CAR-T treatment. Participation in the study also includes computer-based cognitive testing, neuropsychological evaluation and genetic testing to determine whether the patient has receptors allowing binding of the TSPO radioligand used during PET imaging.

Key facts

Study ID

NCT07375628

Run by

Karolinska University Hospital

People needed

10

Starts

2026-02-01

Expected to finish

2029-05-01

Last updated by the study team

2026-01-29

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 20
• Planned to undergo CAR-T treatment
• No known prior CNS diseases or head trauma
• Prior CNS involvement of lymphoma or acute lymphoblastic leukemia is allowed, provided it is well-controlled and treated at inclusion
• Capable of receiving tailored information about the research project and signing informed consent

You may not qualify if…

• • Age under 20 years
• The patient has previously indicated they wish to refrain from research participation
• Another concurrent neuroinflammatory or neurodegenerative disease, or malignant disease (other than the underlying condition) in the central nervous system

Full record on ClinicalTrials.gov

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