CAR T Cell TherapyNCT07375628
Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond
An observational study of CAR T Cell Therapy and ICANS, run by Karolinska University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- CAR T Cell Therapy, ICANS, Cognitive and Executive Dysfunction
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be patients with various hematologic diagnoses undergoing CAR-T. These patients are identified during routine care at ME CAST, Karolinska University Hospital. Only adults (over 20 years) will be included.
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kirsti Niemelä, study nurse contact
About this study
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.
Read the detailed description
Neurological symptoms after immune effector cell therapy are poorly understood, even though acute neurological adverse events have been reported for all CAR T-cell products. Adverse events affecting the central nervous system (CNS) during CAR-T-cell treatment-known as Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)-typically occur about 4-10 days after treatment and cause symptoms such as confusion and speech difficulties. The incidence of ICANS ranges from as low as 2% to as high as 60%-70%. Despite many research projects and clinical trials, the pathogenesis of acute neurological toxicity remains unclear. Although the acute symptoms of ICANS are well characterized, little is known about long-term effects regarding fatigue and cognitive function after this treatment.
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. Although the life-threatening phase may resolve within a few days thanks to rapid diagnostics and optimized treatment, some patients develop more long-lasting symptoms. These patients may experience reduced quality of life and difficulty returning to work and daily routines. Unfortunately, it is currently difficult to quantify and grade these symptoms, which complicates, for example, sickness certification or rehabilitation. Moreover, knowledge is very limited regarding the pathophysiological factors underlying symptoms such as fatigue and cognitive difficulties, and treatment options are limited.
Based on our results in allogeneic stem cell-transplanted patients and prior research on ICANS, our hypothesis is that clinical tools can predict high risk for ICANS and that long-term symptoms are caused by persistent low-grade inflammation in the brain after the acute phase. We believe that patients have dysregulated microglial cells and injury to synaptic function in neurons. Previous research has shown that a reduced number of connections between nerve cells (synapses) causes mental fatigue and cognitive difficulties in several psychiatric and neurodegenerative disorders.
We now 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. Understanding the relationship between neuroinflammation and synapse loss and how this can lead to cognitive difficulties may ultimately lead to new treatment methods. We will collect blood and cerebrospinal fluid (CSF) samples from this patient cohort. Blood samples will be taken from all patients before, during, and after CAR-T treatment. In the event of ICANS, a lumbar puncture will be performed according to clinical routine and CSF will be collected for microbiological analyses, cell counts, biochemistry, flow cytometry, etc., with the addition of research samples. CAR-T cells will be quantified in blood and CSF. During the acute phase, patients with ICANS will undergo neuroimaging with CT and/or MRI. Much of the above already forms part of routine diagnostics, which we now wish to analyze prospectively. Participation in the study also includes computer-based cognitive testing and genetic testing to determine whether the patient has receptors allowing binding of the TSPO radioligand used during PET imaging.
We will also use SWECARNET, our national Swedish CAR-T cell network, to improve knowledge about ICANS and implement it into standard care. The primary aim is to perform in-depth descriptive analyses in patients with ICANS grades 2-4 and 0-1. The scientific objective is to investigate synaptic density, inflammation, and activation of glial cells.
- Keywords
- Icans, CAR T cell therapy, Fatigue, Cognitive dysfunction, PET scan
- Medical subject headings
- Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing CAR T cell therapy in Region Stockholm | This project includes only adult patients (>20 years) in Region Stockholm. Participants will be patients with various hematologic diagnoses undergoing CAR-T. These patients are identified during routine care at ME CAST, Karolinska University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To perform in deep descriptive analysis of patients developing ICANS grade 2-4 compared to patients with no ICANS or ICANS grade 1.
The primary aim is to perform in-depth descriptive analyses in patients with ICANS grades 2-4 and 0-1. The scientific objective is to investigate synaptic density, inflammation, and activation of glial cells, which according to our hypothesis are linked to fatigue and cognitive dysfunction after ICANS. Our hypothesis is that these symptoms are caused by immune activation in the brain, which can be detected, among other methods, by PET imaging. We further hypothesize that this inflammation leads to altered neuronal connectivity with synaptic involvement.
Measured: 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CAR T Cell TherapyStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Kite, A Gilead Company
- Responsible party
- Principal investigator, Ksenia Boriskina, Karolinska University Hospital
- Investigators
- Stephan Mielke, professor, Principal investigator, Karolinska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375628
- Sponsor's protocol ID
- 2025-04301-01
- Other IDs
- 2025
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be discussed
Publications
1. Kazzi C, Kuznetsova V, Siriratnam P, Griffith S, Wong S, Tam CS, Alpitsis R, Spencer A, O'Brien TJ, Malpas CB, Monif M. Cognition following chimeric antigen receptor T-cell therapy: A systematic review. J Autoimmun. 2023 Nov;140:103126. doi: 10.1016/j.jaut.2023.103126. Epub 2023 Oct 12. PMID: 37837807. 2. Gust J, Ponce R, Liles WC, Garden GA and Turtle CJ (2020) Cytokines in CAR T Cell-Associated Neurotoxicity. Front. Immunol. 11:577027. doi: 10.3389/fimmu.2020.577027 3. Morbelli, S., Gambella, M., Raiola, A. M., Ghiggi, C., Bauckneht, M., Di Raimondo, T., Lapucci, C., Sambuceti, G., Inglese, M., & Angelucci, E. Brain FDG-PET findings in chimeric antigen receptor T-cell therapy neurotoxicity for diffuse large B-cell lymphoma. Journal of Neuroimaging 2023 DOI: 10.1111/jon.13135 4. Vinnakota, J.M., Biavasco, F., Schwabenland, M. et al. Targeting TGFβ-activated kinase-1 activation in microglia reduces CAR T immune effector cell-associated neurotoxicity syndrome. Nat Cancer 5, 1227-1249 (2024). https://doi.org/10.1038/s43018-024-00764-7 5. Chauveau, F., Winkeler, A., Chalon, S. et al. PET imaging of neuroinflammation: any credible alternatives to TSPO yet?. Mol Psychiatry 30, 213-228 (2025). https://doi.org/10.1038/s41380-024-02656-9 6. Vardy J, Wong K, Yi QL, Park A, Maruff P, Wagner L, Tannock IF. Assessing cognitive function in cancer patients. Support Care Cancer. 2006 Nov;14(11):1111-8. doi: 10.1007/s00520-006-0037-6. Epub 2006 Mar 15. PMID: 16538498. 7. Meyer JH, et al. Neuroinflammation in psychiatric disorders: PET imaging and promising new targets. Lancet Psychiatry. 2020 Dec;7(12):1064-1074. doi: 10.1016/S2215-0366(20)30255-8. Epub 2020 Oct 21. PMID: 33098761; PMCID: PMC7893630. 8. Kreisl WC, et al. PET imaging of neuroinflammation in neurological disorders. Lancet Neurol. 2020 Nov;19(11):940-950. doi: 10.1016/S1474-4422(20)30346-X. PMID: 33098803; PMCID: PMC7912433. 9. Masdeu JC, Pascual B, Fujita M. Imaging Neuroinflammation in Neurodegenerative Disorders
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond
- ClinicalTrials.gov ID
- NCT07375628
- Acronym / sponsor ID
- 2025-04301-01
- Keywords
- Icans, CAR T cell therapy, Fatigue, Cognitive dysfunction, PET scan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Kite, A Gilead Company
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurological symptoms after immune effector cell therapy are poorly understood, even though acute neurological adverse events have been reported for all CAR T-cell products. Adverse events affecting the central nervous system (CNS) during CAR-T-cell treatment-known as Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)-typically occur about 4-10 days after treatment and cause symptoms such as confusion and speech difficulties. The incidence of ICANS ranges from as low as 2% to as high as 60%-70%. Despite many research projects and clinical trials, the pathogenesis of acute neurological toxicity remains unclear. Although the acute symptoms of ICANS are well characterized, little is known about long-term effects regarding fatigue and cognitive function after this treatment.
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. Although the life-threatening phase may resolve within a few days thanks to rapid diagnostics and optimized treatment, some patients develop more long-lasting symptoms. These patients may experience reduced quality of life and difficulty returning to work and daily routines. Unfortunately, it is currently difficult to quantify and grade these symptoms, which complicates, for example, sickness certification or rehabilitation. Moreover, knowledge is very limited regarding the pathophysiological factors underlying symptoms such as fatigue and cognitive difficulties, and treatment options are limited.
Based on our results in allogeneic stem cell-transplanted patients and prior research on ICANS, our hypothesis is that clinical tools can predict high risk for ICANS and that long-term symptoms are caused by persistent low-grade inflammation in the brain after the acute phase. We believe that patients have dysregulated microglial cells and injury to synaptic function in neurons. Previous research has shown that a reduced number of connections between nerve cells (synapses) causes mental fatigue and cognitive difficulties in several psychiatric and neurodegenerative disorders.
We now 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. Understanding the relationship between neuroinflammation and synapse loss and how this can lead to cognitive difficulties may ultimately lead to new treatment methods. We will collect blood and cerebrospinal fluid (CSF) samples from this patient cohort. Blood samples will be taken from all patients before, during, and after CAR-T treatment. In the event of ICANS, a lumbar puncture will be performed according to clinical routine and CSF will be collected for microbiological analyses, cell counts, biochemistry, flow cytometry, etc., with the addition of research samples. CAR-T cells will be quantified in blood and CSF. During the acute phase, patients with ICANS will undergo neuroimaging with CT and/or MRI. Much of the above already forms part of routine diagnostics, which we now wish to analyze prospectively. Participation in the study also includes computer-based cognitive testing and genetic testing to determine whether the patient has receptors allowing binding of the TSPO radioligand used during PET imaging.
We will also use SWECARNET, our national Swedish CAR-T cell network, to improve knowledge about ICANS and implement it into standard care. The primary aim is to perform in-depth descriptive analyses in patients with ICANS grades 2-4 and 0-1. The scientific objective is to investigate synaptic density, inflammation, and activation of glial cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing CAR T cell therapy in Region Stockholm | – | –This project includes only adult patients (>20 years) in Region Stockholm. Participants will be patients with various hematologic diagnoses undergoing CAR-T. These patients are identified during routine care at ME CAST, Karolinska University Hospital. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients with various hematologic diagnoses undergoing CAR-T. These patients are identified during routine care at ME CAST, Karolinska University Hospital. Only adults (over 20 years) will be included.
Key inclusion criteria (5 listed)
- Age > 20
Key exclusion criteria (3 listed)
- • Age under 20 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To perform in deep descriptive analysis of patients developing ICANS grade 2-4 compared to patients with no ICANS or ICANS grade 1.
Time frame: 2028
The primary aim is to perform in-depth descriptive analyses in patients with ICANS grades 2-4 and 0-1. The scientific objective is to investigate synaptic density, inflammation, and activation of glial cells, which according to our hypothesis are linked to fatigue and cognitive dysfunction after ICANS. Our hypothesis is that these symptoms are caused by immune activation in the brain, which can be detected, among other methods, by PET imaging. We further hypothesize that this inflammation leads to altered neuronal connectivity with synaptic involvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background1. Kazzi C, Kuznetsova V, Siriratnam P, Griffith S, Wong S, Tam CS, Alpitsis R, Spencer A, O'Brien TJ, Malpas CB, Monif M. Cognition following chimeric antigen receptor T-cell therapy: A systematic review. J Autoimmun. 2023 Nov;140:103126. doi: 10.1016/j.jaut.2023.103126. Epub 2023 Oct 12. PMID: 37837807. 2. Gust J, Ponce R, Liles WC, Garden GA and Turtle CJ (2020) Cytokines in CAR T Cell-Associated Neurotoxicity. Front. Immunol. 11:577027. doi: 10.3389/fimmu.2020.577027 3. Morbelli, S., Gambella, M., Raiola, A. M., Ghiggi, C., Bauckneht, M., Di Raimondo, T., Lapucci, C., Sambuceti, G., Inglese, M., & Angelucci, E. Brain FDG-PET findings in chimeric antigen receptor T-cell therapy neurotoxicity for diffuse large B-cell lymphoma. Journal of Neuroimaging 2023 DOI: 10.1111/jon.13135 4. Vinnakota, J.M., Biavasco, F., Schwabenland, M. et al. Targeting TGFβ-activated kinase-1 activation in microglia reduces CAR T immune effector cell-associated neurotoxicity syndrome. Nat Cancer 5, 1227-1249 (2024). https://doi.org/10.1038/s43018-024-00764-7 5. Chauveau, F., Winkeler, A., Chalon, S. et al. PET imaging of neuroinflammation: any credible alternatives to TSPO yet?. Mol Psychiatry 30, 213-228 (2025). https://doi.org/10.1038/s41380-024-02656-9 6. Vardy J, Wong K, Yi QL, Park A, Maruff P, Wagner L, Tannock IF. Assessing cognitive function in cancer patients. Support Care Cancer. 2006 Nov;14(11):1111-8. doi: 10.1007/s00520-006-0037-6. Epub 2006 Mar 15. PMID: 16538498. 7. Meyer JH, et al. Neuroinflammation in psychiatric disorders: PET imaging and promising new targets. Lancet Psychiatry. 2020 Dec;7(12):1064-1074. doi: 10.1016/S2215-0366(20)30255-8. Epub 2020 Oct 21. PMID: 33098761; PMCID: PMC7893630. 8. Kreisl WC, et al. PET imaging of neuroinflammation in neurological disorders. Lancet Neurol. 2020 Nov;19(11):940-950. doi: 10.1016/S1474-4422(20)30346-X. PMID: 33098803; PMCID: PMC7912433. 9. Masdeu JC, Pascual B, Fujita M. Imaging Neuroinflammation in Neurodegenerative Disorders
- Individual participant dataSharing planned: Undecided. to be discussed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsti Niemelä, study nurse contact
Stephan Mielke, professor principal investigator
Karolinska
Questions about this trial
What is this clinical trial studying?
An observational study of CAR T Cell Therapy and ICANS, run by Karolinska University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ksenia Boriskina, MD (+46812380675, ksenia.boriskina@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To perform in deep descriptive analysis of patients developing ICANS grade 2-4 compared to patients with no ICANS or ICANS grade 1. (time frame: 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07375628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.