UC Davis Health Clinical Studies

A Study of Experimetnal VarIthena on Wound Healing in Venous Leg Ulcers (VLU)

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The purpose of this registry is to look at how experimental Varithena® injectable foam works. It will be given to patients who have chronic venous insufficiency (commonly known as “varicose veins”) with leg wounds. The decision to provide you with such medication has been left up to your treating physician and is not being driven by or impacted by this study. The purpose of this project is to collect data about your leg wounds. We hope to learn the impact of treatment on the rate of healing, the rate of repeated wounds, as well as the impacts to your level of pain and quality of life.

Drug study
Any, age 18 years or older

Safety and Dose Study of an Experimental Viral Vector Used for Gene Transfer in Hemophilia A Participants

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This study will test a study drug called experimental BAX 888. It is known as a gene transfer product for people with severe hemophilia A. This is a first-in-human clinical research study, which means BAX 888 has not been tested in human subjects before. The use of BAX 888 in this research study is investigational. This means that BAX 888 has not been approved by the FDA to treat hemophilia A. There is currently not enough information to know how well BAX 888 works to treat conditions like hemophilia A. This will be examined in this clinical research study. The main goals of this study are: • To investigate the safety of BAX 888 when it is given as a single infusion (a slow injection into a vein) to subjects with hemophilia A. • To investigate the optimum amount of BAX 888 necessary for the human body to produce enough Factor 8. • To look at how BAX 888 affects your immune system and the activity of clotting Factor 8 in your blood. • To answer scientific questions about gene transfer for hemophilia A.

Drug study, Phase [/1/,/ /2/]
Male, age 18 to 75 years old

A Study of Experimental ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (liver cancer)

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The purpose of this study is to find out if Study Drug ET140202 T cells are safe and if there are beneficial effects in people with liver cancer. The investigational study drug is ET140202 T cells. The word “investigational” means the study drug is still being tested in research studies and is not approved by the FDA. Your ET140202 T cell product will be made from your own T cells, a specific type of white blood cell. Your T cells will be genetically-modified in the laboratory. This means the T cells are changed by inserting additional pieces of DNA (genetic material) into the cells. This makes them recognize and kill liver cancer cells. The process of making your ET140202 T cell product is described here: • Your cells will be collected by a procedure called leukapheresis. This involves collecting your blood and separating your white blood cells from other blood components. • Your T cells, a specific type of white blood cell, will be isolated and grown in the laboratory. • Your T cells will be treated with a vector. Vectors are type of virus that can enter cells and can change the way the cell acts. • After adding the new ET140202-specific genetic material, your ET140202 T cells will be grown to larger numbers. Afterwards, the cells are washed to select the best cells and frozen. • Your ET140202 T cells will be tested to make sure they are safe for use and then administered to you.

Biological study, Phase [/1/,/ /2/]
Any, age 18 years or older

A Study to Evaluate an Experimental Tricuspid Valve Repair System (TRILUMINATE Study)

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This research study will test the performance of the experimental tricuspid valve repair system. It will be given with standard of care drug therapy. The study team will compare this experimental treatment to standard of care drug therapy alone. You are being asked to take part in this study because you have moderate or greater tricuspid regurgitation (TR). You have been determined to have symptoms due to heart failure despite treatment. TR occurs when your tricuspid valve does not close properly. This causes blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The Study consists of two arms: Randomized Arm and a Single Arm. An independent committee will review screening results and randomly assign participants to each treatment group.

Device study
Any, age 18 years or older

A Study of Engineered Donor Grafts (TregGraft) for Allogeneic Transplantation for Hematologic Malignancies (blood cancer)

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You are being asked to take part in a research study of a type of blood stem cell transplant called TregGraft. TregGraft is being tested as a possible treatment of blood cancers and conditions highly likely to turn into blood cancer. TregGraft is an experimental therapy, meaning that it is not approved by the FDA. TregGraft is the study treatment in this research study. You will not receive TregGraft. Rather, it is the blood cell transplant that will be given to the recipient and will be made from your blood cells. A key part of TregGraft are healthy blood-forming cells. These will be isolated from your blood cells. When placed in the recipient’s bloodstream, they will grow and make new healthy red blood cells, white blood cells, and platelets. TregGraft also includes other specific white blood cell populations including regulatory T cells. These will also be isolated from your blood cells. When given to transplant recipients, they may prevent some of the known complications of blood cell transplants. One example is graft-versus-host disease (GVHD), a condition that involves the immune attack on recipient tissues by donor cells. TregGraft also includes “conventional” T cells, that may help fight infection or cancer, but also carry a risk of causing GVHD.

Biological study, Phase 1
Any, age 18 to 65 years old

Study on Experimental Olaparib Plus Abiraterone for Metastatic Castration-resistant Prostate Cancer

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This research study is for patients who have metastatic Castration-resistant Prostate Cancer (mCRPC). The reason for the study is to find a more effective treatment for this disease. The research team hopes to find out if an experimental medication called olaparib is safe and effective. It will be tested in patients who are also given abiraterone treatment. Olaparib (tradename Lynparza™) is approved by the FDA for other types of cancer. It is considered experimental in this study. Abiraterone is already an approved medication for the treatment of some patients with prostate cancer.

Drug study, Phase 3
Male, age 18 to 99 years old

A Study of Experimental Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Eczema)

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This study will test the effectiveness and safety of the experimental study drug upadacitinib (ABT-494). It will be compared to a placebo, which is an inactive substance that looks like the study drug. Experimental ABT-494 is being tested for the treatment of moderate to severe atopic dermatitis (AD). The study drug is an oral medication (taken by mouth) that is a tablet taken once a day. An experimental drug is one that has not been approved by the FDA.

Drug study, Phase 3
Any, age 12 to 75 years old

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
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