Biomarker and Imaging Package Study in Immune Effector Ce... | NCT05643092

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

NCT05643092

Sponsor

zhang shoulong

Status

Recruiting

Last Update Posted

Mar 7, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Immune Effector Cell Associated Neurotoxicity Syndrome

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 21, 2022

First Submission Date that Met QC Criteria

Dec 1, 2022

First Posted Date

Dec 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2023

Last Update Posted Date

Mar 7, 2023Actual

Name	Class
Jinan Military General Hospital	OTHER
Changhai Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To identify biomarkers for ICANS	Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)	up to 1 years post CAR T-cell infusion
MRI scans for ICANS

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shoulong Zhang	Contact	86-0311-98224		longer_human007@126.com

Overall Officials

Name	Affiliation	Role
Shoulong Zhang	980th Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
980th Hospital	Recruiting	Shijiazhuang	Hebei		China