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

Hannover Medical School (MHH)

Status: Enrolling

Conditions: Cytokine Release Syndrome; CAR-T

Treatments: Device: Cytosorb

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04048434

CRS01

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Standard of care (SOC)

No Intervention group

Cyotosorb

Experimental group

Treatment:

Device: Cytosorb