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

zhang shoulong

Status: Enrolling

Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT05643092

168

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 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