Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Immune Effector Cell Associated Neurotoxicity Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Incidence of CAR-T-associated Neurotoxicity [Time frame: up to 3 years post CAR T-cell infusion]
Secondary outcome measures (2)
- To identify biomarkers for ICANS [Time frame: up to 1 years post CAR T-cell infusion]
- MRI scans for ICANS [Time frame: up to 1 years post CAR T-cell infusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- 980th Hospital — Shijiazhuang
Identifiers
NCT: NCT05643092 · 168