Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
Sponsorzhang shoulong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must be ≥ 18 years of age at signing of informed consent.
Subjects are scheduled to receive CAR T-cell treatment.
Disqualifiers
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
Trial population
This is a prospective observational study using a consecutive patient sample.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of CAR-T-associated Neurotoxicity
The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT
Time frame
up to 3 years post CAR T-cell infusionSecondary outcomes
1
To identify biomarkers for ICANS
Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)
Time frame
up to 1 years post CAR T-cell infusion2
MRI scans for ICANS
Lesion location associated with severity of ICANS
Time frame
up to 1 years post CAR T-cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
zhang shoulong
Lead sponsor
Hebei Medical University
Sponsor institution
Jinan Military General Hospital
Collaborator
Changhai Hospital
Collaborator
Source ClinicalTrials.gov