NCT04048434

Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)

Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Patients with severe CAR-T cell associated cytokine release syndrome (CRS) (defined as vasopressor dependent) will be treated with standard of care (SOC) + cytokine adsorption (6hourly for 24 hrs). Primary endpoint is the change in plasma IL-6 between 0 and 24 hrs.

Conditions

• Cytokine Release Syndrome
• CAR-T

Interventions

Type	Name	Description
DEVICE	Cytosorb	extracorporeal cytokine adsorption

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2019-08-07
• Last updated: 2021-04-01

Locations

2 sites across 2 countries: Germany, Switzerland