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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
zhang shoulong
Lead sponsor
Hebei Medical University
Sponsor institution
Jinan Military General Hospital
Collaborator
Changhai Hospital
Collaborator
Source ClinicalTrials.gov