An observational study in ICANS, Grade Unspecified and CAR T-Cell-Related Encephalopathy Syndrome, sponsored by University of Freiburg. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by University of Freiburg · Observational
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.
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.
758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.
This study's enrollment of 8 is below the median of 100 across 265 observational studies indexed under Brain Diseases.
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Patients that had developed ICANS after CAR T cell infusion will be analyzed.
Exclusion Criteria:
We will study patients that undergo autopsy after CAR T cell infusion.
HLA-DRA and HLA-DR on Iba1+ cells
We will study HLA-DRA and HLA-DR on Iba1+ cells
Time frame: 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
Time frame: 2 years
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Freiburg