Immune Effector Cell Associated Neurotoxicity SyndromeNCT05643092
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
An observational study of Immune Effector Cell Associated Neurotoxicity Syndrome, run by zhang shoulong at 1 site in China.
Trial summary
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Effector Cell Associated Neurotoxicity Syndrome
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2023to Dec 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational study using a consecutive patient sample.
Who may be able to join
- Subjects must be ≥ 18 years of age at signing of informed consent.
- Subjects are scheduled to receive CAR T-cell treatment.
Who cannot join
- Refusal to sign the informed consent
- Subjects having previously been treated with CAR-T therapy.
- Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding
- Subjects presenting primary CNS lymphoma
- Pacemaker or other implanted electrical device incompatible with the MR environment
- Subjects with a neurodegenerative disease (PD, AD)
- Subjects with a previous or evolving neurological pathology
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
980th Hospital
Shijiazhuang, Hebei
Shoulong Zhang
About this study
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.
To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CAR-T-associated Neurotoxicity
The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT
Measured: up to 3 years post CAR T-cell infusion
Secondary outcomes (2)
To identify biomarkers for ICANS
Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)
Measured: up to 1 years post CAR T-cell infusion
MRI scans for ICANS
Lesion location associated with severity of ICANS
Measured: up to 1 years post CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start6 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Effector Cell Associated Neurotoxicity SyndromeStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- zhang shoulong
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Military General Hospital, Changhai Hospital
- Responsible party
- Sponsor-investigator, zhang shoulong, Hebei Medical University
- Investigators
- Shoulong Zhang, Principal investigator, 980th Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643092
- Sponsor's protocol ID
- 168
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
- ClinicalTrials.gov ID
- NCT05643092
- Acronym / sponsor ID
- 168
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- zhang shoulongUniversity, hospital or other
- Collaborators
- Jinan Military General Hospital, Changhai Hospital
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2022 (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.
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.
To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study using a consecutive patient sample.
Key inclusion criteria (2 listed)
- Subjects must be ≥ 18 years of age at signing of informed consent.
- Subjects are scheduled to receive CAR T-cell treatment.
Key exclusion criteria (8 listed)
- Refusal to sign the informed consent
- Subjects having previously been treated with CAR-T therapy.
- Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding
- Subjects presenting primary CNS lymphoma
- Pacemaker or other implanted electrical device incompatible with the MR environment
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
Incidence of CAR-T-associated Neurotoxicity
Time frame: up to 3 years post CAR T-cell infusion
The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT
2 secondary outcomes
To identify biomarkers for ICANS
Time frame: up to 1 years post CAR T-cell infusion
MRI scans for ICANS
Time frame: up to 1 years post CAR T-cell infusion
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 7 Mar 2023.
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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.
Shoulong Zhang principal investigator
980th Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Effector Cell Associated Neurotoxicity Syndrome, run by zhang shoulong at 1 site in China.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shoulong Zhang (86-0311-98224, longer_human007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CAR-T-associated Neurotoxicity (time frame: up to 3 years post CAR T-cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2023.