Clinical Trials

The ITN conducts clinical trials with the goal of achieving immune tolerance for patients. To see a list of ITN's clinical trials that are currently enrolling participants, please select a disease area: 

Allergy & Asthma          Autoimmune Disease          Transplantation         Type 1 Diabetes

To see all of ITN's active and completed studies, please visit For Researchers.

Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (OPTIMAL)

Principal Investigator:
James Markmann, MD, PhD, Massachusettes General Hospital, Boston, MA

OPTIMAL is a clinical trial that will be investigating immunosuppression withdrawal in liver transplant recipients.

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Rituximab Plus Cyclophosphamide followed by Belimumab (CALIBRATE)

Principal Investigator:
Betty Diamond, MD, Feinstein Institute, Manhasset, NY

David Wofsy, MD, University of California San Francisco, San Francisco, CA

The objective of the CALIBRATE study is to determine if treating lupus nephritis with a combination of rituximab (Rituxan®) and cyclophosphamide (Cytoxan®), or a combination of rituximab and cyclophosphamide followed by treatment with belimumab (Benlysta®) is safe and if this drug combination can block the immune system attacks on the kidney.

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Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC) (CAT EEC Study)

Principal Investigator:
Stephen Durham, MD, Imperial College London, London, UK

Piyush Patal, MD, Inflamax Research, Ontario, Canada

The goal of the CAT EEC study is to directly compare allergic responses to cat by environmental exposure chamber vs. nasal allergen challenge to better understand and employ these methods as allergy evaluation tools in clinical trials.

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Preserving Beta-Cell Function with Tocilizumab in New-Onset Type 1 Diabetes (EXTEND)

Principal Investigator:
Carla Greenbaum, MD, Benaroya Research Institute, Seattle, WA

Jane Buckner, MD, Benaroya Research Institute, Seattle, WA

EXTEND is a clinical research study that will test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking the remaining beta cells and possibly extend the ability to naturally produce insulin in individuals recently diagnosed with type 1 diabetes.

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Anti-TSLP Plus Antigen-Specific Immunotherapy For Induction Of Tolerance In Individuals With Cat Allergy (CATNIP)

Principal Investigator:
Jonathan Corren, MD, University of California, Los Angeles, Los Angeles, CA

CATNIP is a clinical research trial, which will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP antibody being co-developed by Amgen and Medimmune) can lead to lasting tolerance to cat allergen. This study will implement the concept referred to as “allergen-plus,” which aims to enhance the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with other anti-inflammatory or immune-modulating agents.

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Research Study of ATG and Rituximab in Renal Transplantation (RESTARRT)

Principal Investigator:
James Markmann, MD, Massachusetts General Hospital, Boston, MA

The purpose of the RESTARRT study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long-term immunosuppressive medication.

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