The purpose of this study is to test the safety of NXC-201 at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis.
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells (a type of white blood cell that is part of the immune system) in the bone marrow. Misfolded proteins produced by these cells can build up in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage.
NXC-201 is made using a person's own T Cells (immune system cells that protect the body from infections, cancer, and other possible harms). The T cells are collected then genetically modified (changes are made to the DNA or genes) outside of the body in a laboratory. A virus is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells. The virus then becomes inactive. The changes are designed to help the NXC-201 cells find and destroy plasma cells that have a protein on their surface called B-cell maturation antigen (BCMA). T-cell therapies like NXC-201 are called CAR T-cell therapies. After being reinjected, the CAR-T cells multiply and spread throughout the body.
NXC-201 is an investigational "treatment", which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of AL Amyloidosis or any other disease.
Calling the study drug a "treatment" in this consent form does not indicate that it will be effective in treating your AL Amyloidosis.
Before receiving NXC-201, participants will receive lymphodepleting chemotherapy (or lymphodepletion) with cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. The lymphodepletion will help prepare the body for receiving NXC-201. Cyclophosphamide and fludarabine are FDA-approved for use as lymphodepleting chemotherapy.
This study is sponsored by Nexcella, Inc., which is responsible for funding and organizing the study.
This study is for patients who have been diagnosed with bladder cancer and are eligible to receive chemotherapy and radiation therapy while keeping their bladder. The study is testing an investigational radiation schedule called stereotactic body radiation therapy (SBRT), which delivers higher doses of radiation over fewer treatment sessions. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).
Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive the usual chemotherapy and standard radiation therapy schedule, which involves lower radiation doses given five days a week for 4 to 5 weeks. The other group will receive the usual chemotherapy and the study radiation schedule (SBRT), which delivers higher doses of radiation in fewer treatments over a shorter period of time.
The primary purpose of this study is to find out whether the shorter radiation schedule is as effective as the usual radiation schedule at preventing bladder cancer from getting worse and avoiding bladder removal surgery.
Radiation therapy and chemotherapy will be given while the bladder remains in place. After treatment is complete, participants will be followed by the study doctor for up to 5 years to monitor for side effects and whether the cancer returns or progresses.
All participants can expect to complete questionnaires about symptoms and quality of life at several time points during and after treatment. These questionnaires are part of the research and will not be shared with treating physicians. There will be a total of 16 patients enrolled locally over 48 months.
This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.
This study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.
This is a Phase II clinical trial testing a drug called Telisotuzumab Vedotin in people who have already been treated for a specific type of lung cancer that has spread or is hard to remove with surgery. The cancer must show high levels of a protein called c-Met and have a normal version of another protein called eGFR. The main goal is to see how well the drug works and how safe it is when given in three different ways. Telisotuzumab Vedotin is a special kind of medicine that combines an antibody (which targets cancer cells) with chemotherapy. It's given through an IV (a tube in your vein), and each treatment takes about 30 minutes. Patients will get this treatment every two weeks on day one of the cycle. There will be four cycles in the study. There is also a 28 day screening window, a 30 day follow up period, post treatment follow up, and then survival follow up. The study itself will only last a few months, but the follow up will last for years. The follow up period will have limited contact compared to the main study. There will be around about 10 total study visits.
This study is for patients that have been diagnosed with non-small cell lung cancer (NSCLC). This study is testing an investigational drug called Amivantamab. "Investigational" means that is not been approved by United States Food and Drug Administration (FDA). There will be no randomization in this study. Participants will be assigned to treatment upon enrollment based on disease treatment status. The primary purpose of this study is to understand how well the study treatment works and the safety of the combination of Amivantamab and Lazertinib in participants who have NSCLC with a specific eGFR mutation. Amivantamab can be given under the skin (subcutaneous) or by infusion (IV). Participants can be in the study for up to 36 months depending on how the participants disease responds to treatment.
Half of caregivers in the US are adults caring for a parent, and many of these are young adults, between the ages of 18-35. This presents communication and quality of life challenges for both the young adult child caregiver and parent with cancer; however, this dyad (e.g., two people together) has not been well studied. We will conduct interviews with young adult child caregivers and parents with cancer to learn more about communication challenges and support needs in this dyad. Dyad members will also complete self-report measures asking about mood, coping, communication and quality of life. Findings will inform the development of an intervention to improve dyadic communication and quality of life.
This study is for patients who have completed curative-intent treatment for colorectal cancer. It is testing an educational website called Current Together After Cancer (CTAC) to see if it improves follow-up care, including knowledge about cancer recurrence, recommended tests, and self-management of health. Participants will be randomly assigned to one of two versions of the website, with or without additional features for engaging a support person, and can use it on a computer, tablet, or smartphone. The study will last up to 16 months, including website use, surveys, and optional interviews, with participation completely voluntary. The goal is to determine whether CTAC helps patients better understand follow-up care and engage their supporters to improve adherence to recommended surveillance. There will be a total of 21 patients enrolled locally over the course of 36 months.
This study is for adults aged 18 to 39 who have a history of cancer and have not had inherited cancer genetic testing. The purpose of this study is to find out if a digital tool can be used as an alternative to meeting with a genetic counselor before inherited cancer genetic testing, and whether this approach can help support patients through the testing process. The study will compare the digital tool to the usual approach for genetic testing, which involves meeting with a genetic counselor before and after testing.
Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive pre-test education through a digital tool, and the other group will meet with a genetic counselor through a telehealth visit. All participants will receive their genetic test results through a telehealth visit with a genetic counselor. Participants in the digital tool group will also have access to a chatbot called the Genetics Journey Chatbot that provides educational support, reminders, and answers to questions during the study.
The study involves completing surveys at several time points: before genetic testing, after the testing decision, after receiving results, and again about 6 and 12 months later. The total duration of participation is about 18 months.
This study does not involve an investigational drug. Participants may benefit from learning whether they have a genetic change that could increase their risk of cancer, which could inform their future screening or prevention options. The information learned from this study may also help improve genetic testing delivery for future patients.
There will be a total of 10 patients enrolled locally over the course of 24 months.
This study is recruiting non-metastatic breast cancer survivors who were diagnosed between ages 18 and 51 and are currently 6 months to 5 years post-treatment. Eligible participants must have a score of 5–14 on the PHQ-8 depression screening tool. This study is testing a digital mindfulness meditation-based program. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Participants will be randomly assigned (like drawing one number out of three at random) to one of three groups: (1) live online mindfulness classes over Zoom, (2) a specially designed mindfulness app, or (3) guided audio meditations. The primary purpose of this study is to determine if different ways of delivering digital mindfulness training can improve mental health and well-being in younger breast cancer survivors. The program is delivered either by live online sessions, through a mobile app, or by listening to guided meditation recordings. Participants can expect to be in this study for about 9 months, including a 6-week training program and questionnaires before, during, and after training. Participants will be enrolled for a duration of 9 months, and a total of 15 patients will be recruited locally over the course of 36 months.