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

NCT05643092 | Recruiting

• 1 other identifier: 168
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of CAR-T-associated Neurotoxicity

  The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT

  up to 3 years post CAR T-cell infusion

Secondary Outcomes (2)

• To identify biomarkers for ICANS

  up to 1 years post CAR T-cell infusion

• MRI scans for ICANS

  up to 1 years post CAR T-cell infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study using a consecutive patient sample.

You may qualify if:

• Subjects must be ≥ 18 years of age at signing of informed consent.
• Subjects are scheduled to receive CAR T-cell treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• zhang shoulong: lead
• Jinan Military General Hospital: collaborator
• Changhai Hospital: collaborator

Study Sites (1)

980th Hospital

Shijiazhuang, Hebei, China

RECRUITING

Study Officials

• Shoulong Zhang

  980th Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shoulong Zhang

CONTACT

86-0311-98224; longer_human007@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 8, 2022
• Study Start: March 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CN (1)