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Not Yet Recruiting NCT05643092

Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome

Sex: All
Ages: 18 Years – 80 Years
Enrollment: 50
Sponsor: zhang shoulong

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. 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

Inclusion Criteria:Subjects must be ≥ 18 years of age at signing of informed consent.Subjects are scheduled to receive CAR T-cell treatment.Exclusion Criteria:Refusal to sign the informed consentSubjects having previously been treated with CAR-T therapy.Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleedingSubjects presenting primary CNS lymphomaPacemaker or other implanted electrical device incompatible with the MR environmentSubjects with a neurodegenerative disease (PD, AD)Subjects with a previous or evolving neurological pathologyPregnant or breastfeeding women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05643092). StuddyBuddy aggregates publicly available trial information.