Clinical Trials

The purpose of this study is to develop a novel immunotherapeutic strategy to treat Recurrent Respiratory Papillomatosis (RRP) patients and cure the disease.

The primary objective of this study is to evaluate markers of eosinophilic inflammation in the esophagus longitudinally in subjects on milk oral immunotherapy (OIT) or placebo.

This is a companion study to a parent clinical trial which is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in subjects aged 4 to 50 years inclusive who are allergic to milk. The parent study consists of a screening period, a 24-week treatment period, which includes 4 weeks of pre-treatment with dupilumab or placebo followed by 12 weeks of treatment with dupilumab or placebo in combination with a gradual up-dosing of milk protein ...

The purpose of this study is to test (in 2 stages) the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in HIV-1 infected participants undergoing antiretroviral therapy (ART) interruption.

The purpose of this study is to assess the safety, tolerability, and effectiveness of AMT-101 in subjects with chronic antibiotic-resistant pouchitis, and to select an AMT-101 dose for Phase 3.

The purpose of this study is to evaluate the role of interferon-gamma (IFN-γ) in antifungal defense and its potential use in adjunctive immunotherapy.  Solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients are at increased risk for invasive fungal infections.  Mortality rates remain unacceptably high despite antifungal treatment. Novel therapeutic modalities are urgently needed. In this project, we propose to study the role of interferon-gamma (IFN-gamma) in antifungal defense and its potential use in adjunctive immunotherapy. 

The purpose of this study is to determine whether INO-8000 alone or in combination with INO-9012 (IL-12) is safe and induces a Hepatitis C virus-specific immune response.

This study seeks to understand the treatment experiences and side effect reporting behavior of Stage III and IV melanoma patients who have undergone immunotherapy.  

Characterize and identify the immune phenotype of patients with multiple myeloma by flow cytometry of peripheral blood circulating and bone marrow immune cells and by testing the immunogenticity of these cells in vitro. Samples will be collected from patients longitudinally at baseline and post treatments to examine the effect of treatments on host immunity. The treatments include IMiDs, proteosome inhibitors, chemotherapy, monoclonal antibodies and stem cell transplantation.To c

The purpose of this study is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves desensitization and safety, defined as an increase in the proportion of subjects who pass a double-blind placebocontrolled food challenge (DBPCFC) to at least 2040 mg cumulative milk protein at week 18.

The purpose of this study is to evaluate the effectiveness and safety of intracoronary delivery of autologous CD34+ cells (CLBS16) in subjects with coronary microvascular dysfunction (CMD) and without obstructive coronary artery disease

The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

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.

This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and compare every 2 week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants ...

The purpose of this study is to determine the overall survival of patients treated with Vigil versus gemcitabine/docetaxel.

The purpose of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity will be needed to proceed to stage 2.

To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell product targeting a protein commonly found on myeloma cells called BCMA. Patients will be given a 3 day course of chemotherapy followed by a single infusion of KITE-585.

The purpose of this early phase I pilot trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating participants with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma.

A third cohort of patients (Arm C) will receive tiragolumab and atezolizumab for neoadjuvant therapy, and atezolizumab alone for adjuvant therapy.

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.

The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.