NCT05811117

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University of Freiburg · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2021-04-12
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2023-04-13
• Last updated: 2023-05-16

Locations

1 site across 1 country: Germany