IL-2 in Refractory Autoimmune Encephalitis

• Status: Completed
• Trial end date: 2019-06-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether low-dose IL-2 is effective in refractory autoimmune encephalitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Aldesleukin

Criteria

Inclusion Criteria:

• Age > 18 years

• Clinical diagnosis of autoimmune encephalitis

• Positive for autoantibody (serum and or CSF) : NMDAR, anti-leucine-rich glioma inactivated-1(LGI-1), contactin-associated protein-like 2 (CASPR2), α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA) 1, AMPA2, GABAB-R, anti-Hu, -Yo, -Ri, -Ma2, -CV2/collapsing response mediator protein 5 (CRMP5), -amphiphysin, or glutamic acid decarboxylase (GAD)

• Refractory to first-line (high-dose steroid or intravenous immunoglobulin) and second line (rituximab or cyclophosphamide) immunotherapy

• Written informed consent form.

Exclusion Criteria:

• low hemoglobin <8.0 g/dL, absolute neutrophil count<1600/mm3, lymphocytes <600/mm3, platelets <140,000/mm3

• heart failure (≥ grade III NYHA), hepatic insufficiency (aspartate amino transferase >200 IU/L, amino alanine transferase, >200 IU/L), or lung failure

• Positive for HIV serology, active hepatitis B

• Significant abnormality in chest X-ray other than these linked to the diseases under investigation

• Infection

• Other progressive neurological degenerative disease.

• Poor venous access not allowing repeated blood tests

• pregnant or lactating women