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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04048434

Acronym

CYTORELEASE

Enrollment

Registered

2019-08-07

Start date

2021-06-30

Completion date

2024-09-30

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAR-T, Cytokine Release Syndrome

Brief 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.

Interventions

DEVICECytosorb

extracorporeal cytokine adsorption

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* severe CRS (\> 3) and / or severe CRES (\>3) AND \- CRS/CRES onset \< 6 hrs

Exclusion criteria

* Heparine allergy * contraindication for anticoagulation

Design outcomes

Primary

Measure	Time frame
IL-6 change	24 hours

Countries

Germany, Switzerland

Contacts

Primary ContactSascha David, MD

david.sascha@mh-hannover.de+495115329357

Backup ContactKlaus Stahl, MD

stahl.klaus@mh-hannover.de+495115327623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026