NCT05811117

Brief Summary

Immunotherapy with chimeric antigen receptor (CAR) T cell therapy can cause immune effector cell-associated neurotoxicity syndrome (ICANS). However, the molecular mechanisms leading to ICANS are not well understood. In this study, the investigators plan to examine the role of microglia as the primary parenchymal immune cells of the central nervous system (CNS) during ICANS in human samples. The samples will be analyzed using imaging-mass-cytometry-based analysis (IMC). Single-cell data will be obtained through machine learning supervised segmentation of IMC data. Single-cell marker expression in all cells and in microglia (Iba1+ cells) will be analyzed in patients with ICANS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

March 30, 2023

Last Update Submit

May 14, 2023

Conditions

ICANS, Grade UnspecifiedCAR T-Cell-Related Encephalopathy Syndrome

Outcome Measures

Primary Outcomes (2)

  • HLA-DRA and HLA-DR on Iba1+ cells

    We will study HLA-DRA and HLA-DR on Iba1+ cells

    2 years

  • Clusters of activated microglia and macrophages will be studied in patients with ICANS

    Clusters of activated microglia and macrophages will be studied in patients with ICANS

    2 years

Interventions

There will be no intervention as we will study patients that undergo autopsy after CAR T cell infusion.DIAGNOSTIC_TEST

We will study patients that undergo autopsy after CAR T cell infusion.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that had developed ICANS after CAR T cell infusion will be analyzed.

You may qualify if:

  • Patients that had developed ICANS
  • CAR T cell infusion for lymphoid malignancy (NHL or ALL)

You may not qualify if:

  • Lack of consent of patient or legal guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freiburg University Medical Center

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (1)

  • Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.

    PMID: 34260836RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Division of Tumor Immunology

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 13, 2023

Study Start

April 12, 2021

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)