Clinical Trials

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

The purpose of this study is to longitudinally follow Torque Teno Virus (TTV) levels in lung transplant recipients and attempt to find a correlation with infection or rejection events.

Hypothesis: we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection. In addition, oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

Aims, purpose, or objectives:
1. Investigate the frequency Bregs and their ability to express IL-10 along with other immune cells in the context of tolerance/rejection in kidney transplant patients.
we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, ...

The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.

The purpose of this study is to look at the effectiveness of using a study drug called cyclophosphamide (PTCy) to prevent graft versus host disease (GVHD) in individuals who have received a blood stem cell or bone marrow transplant from a donor who is not a perfect match. There are three study groups: one which is for adults who will receive a typical conditioning regiment prior to their peripheral blood stem cell (PBSC) transplant, one for adults which will receive a not as intense conditioning regiment and one for children who will receive a bone marrow transplant.

The purpose of this study of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease is to assess the safety and tolerability of the regimen at week 24 of the desensitization phase and at week 28 post kidney transplantation. All participants will be monitored for a minimum of 12 months following the last obinutuzumab infusion.

The purpose of this study is to assess the safety, tolerability, and dose limiting toxicities of taking a specific combination of immunosuppressant drugs on infused donor-alloantigen-reactive regulatory T cells after liver transplantation, to improve immune function without liver rejection.

The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.

The purpose of this study is to evaluate L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following double-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

The purpose of this study is to identify an optimal dose for GDC-8264 for future studies, using all available safety, pharmacokinetic, and effectiveness data.

The purpose of this study is to determine the incidence of biopsy proven acute rejections detected due to elevated dd-cfDNA independent of change in serum creatinine, to determine incidence of DeNovo Donor specific antibody (DSA) or increase in preexisting DSA’s in presence of elevated dd-cfDNA, and to determine the association of elevated dd-cfDNA with progression of chronic changes in surveillance biopsies.

Nonadherence to immunosuppression is associated with an increased risk for organ rejection, allograft vasculopathy, and death (De Geest et al., 2014). Immunosuppression nonadherence has been found to be a factor in up to 90% of late acute rejection events that occur after the first year following transplant, and in 13% to 26% of deaths among heart transplant recipients in single-center research studies (De Geest et al., 2005). A prospective cohort study found that for individuals who were nonadherent after their first year following transplant, the risk of a negative clinical event was doubled (Dobbels et al., 2004). In ...

The purpose of this study is to evaluate post-transplant clinical outcomes in receipients of kidney transplants who are undergoing TruGraf® and TRAC™ monitoring.

The purpose of this study is to assess the safety, effectiveness, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

This study will compare the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of "immune activation" (IA) on peripheral blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.