UC Davis Health Clinical Studies

A Study of Experimental AB-205 in Adults With Lymphoma Undergoing Autologous (from self) Stem Cell Transplantation

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You are invited to be in this study because you have lymphoma. A clinical trial is a type of research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. Clinical trials include only people who choose to take part. This is a first in-human study. The purpose of this research is to find out if the experimental product, AB-205, is safe. AB-205 is made up of engineered (modified) human endothelial cells. The endothelial cells are cells that line the inside of blood vessels including the umbilical cord. AB-205 is made from human umbilical endothelial cells that are collected from the umbilical cord of a healthy newborn baby. This research study will test the safety of a single dose infusion of AB-205, given after a bone marrow transplant. The study goal is to test the highest dose of AB-205 to be given in humans with Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL). Patients are in a chemo-sensitive remission undergoing high-dose therapy (HDT), with or without radiation. Participants have an autologous stem cell transplant. This is a type of transplant in which a person’s own stem cells are taken, preserved and returned to them.

Biological study, Phase 1
Any, age 18 years or older

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

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The purpose of this study is to test the safety and effectiveness of an experimental cancer treatment called NeoTCR-P1. This is a research study for people who have been diagnosed with cancer. Specifically: - advanced melanoma, - bladder cancer, - colorectal cancer, - ovarian cancer, - breast cancer, or - prostate cancer The study is for patients whose cancer has gotten worse after standard therapy and no additional therapies are available. This research study will take some of your own white blood cells, modify them in a laboratory, and re-infuse them back into you. White blood cells are part of the body’s immune system. They help the body fight infection and other immune diseases. Types of white blood cells are granulocytes (neutrophils, eosinophils, and basophils), monocytes, and lymphocytes (T-cells and B-cells). In this study, your T-cells will be modified so that they can identify and possibly kill your cancer cells. Cancer cells have markers, called “neoantigens”, on their surface that are unique and specific to each person’s tumor. You can think of neoantigens as a tumor’s hidden fingerprint. Your T-cells will be modified to recognize your tumor’s specific neoantigen. The modification is a genetic change, or gene transfer, to your normal T-cells. This means that a section of DNA (genetic material) in your T-cells will be replaced. A specific DNA sequence will be put in its place to help your T-cells identify and locate your tumor cells. A receptor is a protein molecule on a cell’s surface. It receives chemical signals from outside the cell and translates them into a response inside the cell. This modification will add a new receptor to your T-cells so that they recognize cancer cells expressing neoantigens specific to your tumor. This type of genetic modification has not been tested in humans. These modified T-cells are called “NeoTCR-P1” T-cells. NeoTCR-P1 will be given back to you through your vein in one infusion. Unlike standard drugs that are broken down by your body, NeoTCR-P1 is a “living drug.” It is able to proliferate (expand the number and type of stimulated T-cells) extensively in participants. The actual number of cells that expand after infusion will vary from participant to participant. The use of NeoTCR-P1 is experimental and has not been approved by the Food and Drug Administration (FDA) for use outside this study. NeoTCR-P1 is being tested in humans for the first time under this study. Providing your blood for the collection of genetic material to be used in the production of the study drug is not optional in this study.

Biological study, Phase 1
Any, age 18 years or older

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

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We invite you to take part in a research study because your doctor has determined that you have non-ischemic cardiomyopathy. This is the weakening of the heart muscle. It is not caused by coronary artery disease or heart attack. This study is for patients who have recently received an ICD or CRT-D implant. Cardiac rhythm devices help the heart function better. They relieve symptoms and treat life threatening arrhythmias (irregular heart beats). The study is being done to better understand ICD or CRT-D implant. These devices are used to prevent sudden cardiac death. They are give to patients who have not yet experienced a cardiac arrest (heart attack) or life threatening arrhythmias (abnormal heart beats). The outcomes will be evaluated to determine if there are differences between the ICD and CRT-D devices. We will also study the differences in effectiveness between men and women.

Other Study
Any, age 18 years or older

A Study of Experimental Genetic Testing for the APOL1 Gene in Kidney Transplantation (APOLLO Study)

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The purpose of this study is to test kidney donors and kidney transplant recipients for apolipoprotein L1 gene (called APOL1). We will test for this gene and its variants (or forms of the gene). We hope to see how these may affect kidney donors and recipients. Genes control the traits that you inherit from your family such as your eye color or blood type. Variation or changes in genes can also put some people at risk for developing certain diseases. Previous research has shown that variation in the APOL1 gene can put people at higher risk for kidney disease. The purpose of this study is to test kidney donors and recipients for APOL1 gene variants. We hope to learn how this gene may impact people who receive a kidney transplant and those who donated a kidney.

Other Study
Any, age -1 years or older

A Study of Different Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders

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You have been asked to participate because you may have symptoms of: - Rapid-Onset Dystonia-Parkinsonism, - Atypical Parkinsonism, - Dystonia, or other movement disorders, specifically AHC (Alternating hemiplegia of childhood) - Cerebral Palsy patients Dystonia is a movement disorder with involuntary muscle contractions. These force certain parts of the body into abnormal, sometimes painful, movements or postures. Dystonia can affect any part of the body including the arms and legs, trunk, neck, eyelids, face, or vocal cords. You may also be asked to take part if you have a family member with Rapid Onset Dystonia-Parkinsonism (RDP) or other movement disorder. The purpose of this study is to find more information about the symptoms of RDP. We want to learn how many persons have it or the gene for it, and about how the symptoms may change over time. You are free to stop your participation at any time. Currently families with RDP have been identified in the United States and Europe.

Other Study
Any, age 2 years or older

Study of Using "Omics" (genes, metabolites, and proteins from blood and heart tissue) to Learn More About Heart Disease

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This study is being done to find ways to better understand and identify Heart Failure. We are interested in studying “Omics.” This is the study of all molecules, such as genes, metabolites, and proteins in blood, stool, urine and cells of the heart. We will use Omics studies and clinical information to create a comprehensive evaluation of Heart Failure. This will allow us to learn if there are better ways to determine how your heart is doing. Through "Omics" studies, we can identify thousands of genes, metabolites, and proteins. This will help us search for early signs of cardiovascular disease. What we learn can be used to guide treatments and lessen the problems associated with heart disease.

Other study
Any, age 21 years or older

Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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This study is for patients who have Idiopathic Pulmonary Fibrosis (IPF) and are taking Ofev®. Patients with IPF are often referred by their doctors to pulmonary rehabilitation programs. Some patients report that the programs have helped them. This potential benefit has not been studied very much before. This study is being done in patients who have IPF and are taking Ofev® to see: • if pulmonary rehabilitation improves physical activity and quality of life . • if any benefits last after stopping the pulmonary rehabilitation.

Drug study, Phase 4
Any, age 40 years or older
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