Mayo-Adimune Collaborative and Programmatic Approach to Tolerization Therapy

Overview

About this study

The purpose of this study is to target two autoimmune neurological conditions that we consider proof of principal T cell- and antibody-mediated disorders that will provide a substrate for the evaluation of potential effectiveness and broader applicability of the Adimune tolerization strategy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Stiff Person Syndrome or Ataxia or Epilepsy with elevated anti-GAD serum antibody titers > 20 nM/L or CSF antibody titer greater than 0.02 nM/L.
  • Ambulatory with or without gait aid (cane, walker).
  • Willingness to wean IVIg/IST therapy and symptomatic therapies during final 6 months prior to screening for a phase II trial.
  • Patients will be allowed to receive the ongoing non-immunosuppressive drugs used to treat SPS including diazepam, eurontin or baclofen. The dose of these drugs will remain unchanged final 6 months prior to screening for a phase II trial. Willingness and legal ability to give and sign informed study consent.
  • Patients with diabetes (Type I) will be allowed to participate because up to 40% of SPS patients have diabetes.
  • Concurrent enrollment in IRB#08-007846 with skin punch biopsy and lumbar puncture for research only.

Exclusion Criteria:

  • Wheelchair bound.
  • Candidates may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive in the final 6 month prior to screening for the phase II trial.
  • Any medical or social condition that precludes follow-up visits.
  • Any history of cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease. Patients with cardiomyopathy grade III or IV by the New York Heart Classification will be excluded from this study. Systemic edema or pulmonary edema.
  • Chronic liver disease or alcoholism.
  • Any condition, including active infections, that would likely increase the risk of protocol participation or confuse the understanding of the data.
  • Pregnancy. Serum pregnancy test will be performed and must be negative in all women of childbearing potential enrolled in the study.
  • History of active psychiatric disorder that may interfere with participation in the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/24/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Howe, Ph.D.

Open for enrollment

Contact information:

Center for Multiple Sclerosis and Autoimmune Neurology

DLCMSANResCoor@mayo.edu

More information

Publications

Publications are currently not available