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NCT Number: NCT05811117

Multicenter Study Using IMC to Analyze the Impact of ICANS on Microglia

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.

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Key information

Conditions

ICANS, Grade Unspecified CAR T-Cell-Related Encephalopathy Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Freiburg University Medical Center

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

Immunotherapy with chimeric antigen receptor (CAR) T cell therapy can cause immune effector cell-associated neurotoxicity syndrome (ICANS).

Previous studies have shown a role for IL-1beta and IL-6 in xenograft mouse models.

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. The participants are patients treated with chimeric antigen receptor (CAR) T cell therapy. The patients will received TSPO-PET imaging if available and if an autopsy is performed underroutine conditions tissue is collected for IMC based analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of consent of patient or legal guardian

Treatment and study plan

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.

Primary outcomes

  1. HLA-DRA and HLA-DR on Iba1+ cells

    Time frame: 2 years

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

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

Multicenter Study Using Imaging Mass Cytometry to Analyze the Impact of ICANS on Microglia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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