CytoSorbents Corporation (CTSO), a critical care immunotherapy leader commercializing its CytoSorb^® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that Hannover Medical School in Germany will begin the first clinical study called CYTORELEASE, evaluating the use of CytoSorb in treating CRS and inflammation of the brain called CAR-related Encephalopathy Syndrome (CRES), following CAR-T cell immunotherapy.

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The CYTORELEASE trial, entitled “Effectivity of Extracorporeal Cytokine Adsorption (CytoSorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release Syndrome (CRS) and Encephalopathy Syndrome (CRES),” is a randomized, controlled pilot study in 34 cancer patients who have received CAR-T cell immunotherapy and who have developed either severe CRS or CRES for a duration less than 6 hours.  Patients will receive either standard of care therapy versus standard of care therapy plus CytoSorb hemoadsorption.  The primary endpoint of the study is a plasma reduction of the pro-inflammatory cytokine interleukin-6 (IL-6). Secondary and exploratory endpoints will examine other potential clinical benefits such as improvements in CRES, shock, and other organ injury.  The trial has been approved by the Hannover Medical School ethics committee and is ready to begin enrollment.

Principal Investigator Dr. med. Sascha David, Medicine, Division of Nephrology at Hannover Medical School, stated, “We are excited by the theoretical rationale of cytokine adsorption with CytoSorb in treating severe CRS and CAR T-cell related Encephalopathy Syndrome (CRES).  CytoSorb’s potential impact on severe CRES is of special interest, given that CRES is a common and sometimes life-threatening complication of CAR T-cell therapy that is not adequately addressed by IL-6 blockade.  I am looking forward to the results of our first randomized, controlled pilot study.”

CAR-T cell immunotherapy represents a breakthrough in cancer treatment of acute lymphocytic leukemia (ALL) and Diffuse large B-cell lymphoma (DLBCL) that are refractory to standard biologic therapy and chemotherapy, and has great potential in other blood cancers and solid tumors in the future. The therapy takes a patient’s own immune T-cells, genetically modifies them outside of the body with a chimeric antigen receptor (CAR) to be able to recognize and kill the cancer cells, and reinfuses these CAR-T cells back into the body where they have led to dramatic cures of what were considered irreversibly fatal cancers.  However, in doing so the activated cells often trigger an inflammatory response in the patient caused by the production of high levels of inflammatory mediators called cytokines.  In some patients, the levels of these cytokines can spiral upwards, creating a “cytokine storm” or cytokine release syndrome (CRS) that can rapidly cause multi-organ failure, inflammation of the brain, and potentially death if left untreated.  Tocilizumab® (an IL-6 receptor antagonist) and intravenous steroids are the current approved treatments for CRS but are not always successful in controlling CRS or CRES, and have the potential to immune suppress the patient, increasing the risk of serious infection.   CytoSorb has the potential to fill this gap.  There are currently two approved CAR-T cell immunotherapies in both the United States and European Union.  According to Market Research Future, the global CAR T-cell immunotherapy market is expected to approach $9 billion in revenue by 2025.