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

Launched by ZHANG SHOULONG · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can occur in patients receiving CAR T-cell therapy, a treatment for certain blood cancers. The goal of the study is to learn more about how ICANS affects the brain by examining specific brain chemicals and using advanced imaging techniques to see any changes. Researchers hope that this study will help improve the detection and prevention of ICANS in the future.

To participate in the trial, individuals must be at least 18 years old and scheduled to receive CAR T-cell treatment. However, those who have previously had CAR T-cell therapy or have certain medical conditions, such as active bleeding issues or specific neurological diseases, will not be eligible. Participants can expect to have tests that analyze their cerebrospinal fluid (the fluid surrounding the brain and spinal cord) and undergo brain imaging. This research could provide valuable insights into how ICANS affects the brain and help enhance patient care.

Gender

ALL

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 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 Officials