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IL-2 in Refractory Autoimmune Encephalitis

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ClinicalTrials.gov Identifier: NCT02714959
Recruitment Status : Unknown
Verified March 2016 by Kon Chu, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Encephalitis Drug: Proleukin Phase 1 Phase 2

Detailed Description:

Autoimmune encephalitis is a recently recognized etiology of encephalitis which is mediated by various autoantibodies targeting neural cells or synapses. The responses to immunotherapy is generally good, considerable proportion of patients with autoimmune encephalitis have unfavorable clinical outcomes. Recently, depletion of regulatory T cell (Treg cell) is reported in variable autoimmune diseases and multiple studies have shown that low-dose interleukin-2(IL-2) specifically activates Treg cells to control autoimmunity and inflammation.

Protocol: This study is a single arm open-label study assessing clinical responses to the administration of low-dose IL-2 in autoimmune encephalitis patients who are refractory to first- and second-line immunotherapy.

Objective: To assess the efficacy of low-dose IL-2 in autoimmune encephalitis, resistant to first- and second- line immunotherapy.

Methods: This is a single arm open-label study. Each patients will receive four cycles of subcutaneous Proleukin (Interleukin-2, IL-2) (Week-1; 1.5 million IU (MIU)/d from Day-1 to Day-5, Week-3, -6, -9; 3MIU/d from Day-1 to Day-5) in the hospital. The patients will be followed up for 3 months (Week-21).

Primary outcome - clinical efficacy by modified Rankin Scale Secondary outcome - Immunologic follow-up of Treg cells before, during, and after IL-2 therapy, quality of life, cognitive function, side effect of low-dose IL-2


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of IL-2 in Refractory Autoimmune Encephalitis Patients: A Pilot Study
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
Drug Information available for: Aldesleukin

Arm Intervention/treatment
Experimental: Proleukin
Proleukin (subcutaneous injection) 1.5 MIU/day from day 1 to 5 at W1 3 MIU/day from day 1 to day 5 at W3, W6, and W9
Drug: Proleukin



Primary Outcome Measures :
  1. Change of modified Rankin scale [ Time Frame: Week 0,12 ]

Secondary Outcome Measures :
  1. The change of percentage of regulatory T (Treg) cells [ Time Frame: Week 1, 3, 5, 9, 12, 21 ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 1, 3, 5, 9, 12, 21 ]
  3. Quality of life [ Time Frame: Week 21 ]
    Quality of Life in Epilepsy Inventory (QOLIE)-31

  4. Quality of life [ Time Frame: Week 21 ]
    Beck Depression Inventory (BDI)

  5. Cognitive function [ Time Frame: Week 21 ]
    Mini-mental state examination (MMSE)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714959


Contacts
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Contact: Chu Kon, MD, PhD stemcell.snu@gmail.com

Sponsors and Collaborators
Seoul National University Hospital

Publications:

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Responsible Party: Kon Chu, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02714959     History of Changes
Other Study ID Numbers: 1510112713
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents