car t pancreatic cancer clinical trial

CYAD-01 — Celyad‘s CAR T-cell product — is showing promise as a treatment for metastatic colorectal cancer patients (mCRC), both alone and in combination with standard of care chemotherapy, according to findings from two clinical trials. For general information, Learn About Clinical Studies. Step counts appeared to correlate with self-reported quality of life during the first 2 weeks of treatment with SM-88 in patients with metastatic pancreatic cancer, the results of a preliminary exploratory analysis from part 2 of the phase 2/3 TYME-88-Panc trial showed. Patients with the following diagnoses: Cohort 2: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; and either cytologically-proven ascites or known peritoneal disease on radiologic imaging. Intravenous administration of permanently modified CAR T cells that target mesothelin, given as single agent or in combination with a lymphodepleting dose of cyclophosphamide. However, a focus for the field remains the discovery and validation of pancreatic cancer-specific antigens. 16. This determination will be made by a cardiologist if cardiac issues are suspected. Information provided by (Responsible Party): Subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells without any conditioning chemotherapeutic regimen. If CAR-T cell immunotherapy is shown to be effective in fighting pancreatic cancer cells, this revolutionary new treatment will provide much-needed hope for patients who receive the devastating diagnosis of pancreatic cancer. ClinicalTrials.gov Identifier: NCT04404595, Interventional Provides written informed consent. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc). Failure of at least one prior standard of care chemotherapy for advanced stage disease. First, a patient’s own blood is collected and the white blood cells from that collection are separated out, with the remaining red blood cells and plasma returned to the patient, a process known as leukapheresis. All trials available are categorized and can be … A FLEDGLING BUT PROMISING form of immunotherapy known as CAR T cell therapy has been adapted to hit a new biologic target in the hopes that it will effectively fight advanced pancreatic cancer. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). 8. Number of study subjects with treatment-related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 [ Time Frame: 2 years ], Tumor response rates measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria [ Time Frame: Day 28, Month 3, Month 6 ], Progression-free survival (PFS) [ Time Frame: 2 years ], Overall survival (OS) [ Time Frame: 2 years ], Cohorts 1 and -1: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma, Bilirubin must be less than two times (< 2.0x) the institutional normal upper limit, Bilirubin < 2.0x the institutional normal upper limit, Creatinine < 1.5x the institutional normal upper limit, Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5x the institutional normal upper limit. 9. 12. Grant Term: April 2017–March 2019. If zero (0) DLTs occur in three (3) subjects, or if one (1) DLT occurs in six (6) subjects, the study will begin to enroll subjects into Cohort 2. Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding; Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation; Patients requiring anticoagulant therapy such as warfarin or heparin; Patients requiring long-term antiplatelet therapy; Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning; Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately 3 weeks before preconditioning; Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning; Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients; Patients have clinical significant pulmonary conditions; Patients known to have active autoimmune diseases; Patients with second malignancies in addition to STAD or PAAD; Patients have significant neurologic disorders; Patients are unable or unwilling to comply with the requirements of clinical trial. Active invasive cancer other than pancreatic adenocarcinoma. 10. Subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells following a flat dose of 1 gram/m^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (approximately day -4 to day -2). A Phase 1b, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric or pancreatic … Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Two doses (1-3 × 107/m2 and 1-3 × 108/m2) were infused (with or without prior cyclophosphamide) with a lymphodepleting regimen. By rigging a patient’s own T cells into CAR T cells that problem is hopefully overcome. Neoadjuvant Clinical Trial StageVaccines: Pancreas cancer vaccines activate the immune system and lead immune cells, typically unable to detect cancer, to attack the cancer cells in the pancreas and throughout the body. Blood coagulation parameters: PT such that international normalized ratio (INR) is ≤ 1.5 and a PTT < 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters. COVID-19 is an emerging, rapidly evolving situation. Specifically, the study seeks to determine the safety and feasibility of intravenous administration of transduced huCART-meso cells in subjects with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma both with and without cyclophosphamide as lymphodepleting chemotherapy. Filter this list of studies by location, status and more. Any clinically significant pericardial effusion, Class II-IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 3) or other cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. 8. Study record managers: refer to the Data Element Definitions if submitting registration or results information. But sometimes this elegant system is out of sync, and T cells don’t always recognize malignant cells or they don’t mount an offensive against them. Pancreatic Cancer Pipeline by Stages 2. COVID-19 is an emerging, rapidly evolving situation. Search for closest city to find more detailed information on a research study in your area. Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. An indwelling drainage device placed prior to eligibility confirmation by physician-investigator is acceptable. Pregnant or breastfeeding women. Information provided by (Responsible Party): A Phase 1b, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric or pancreatic adenocarcinoma. The trial will take place at Baylor University Medical Center in Dallas. These cohorts will be used to establish the safety of this investigational product (huCART-meso cells) as well as the target dose level in the target study population. A Study to Evaluate the Safety and Tolerability of KTE-X19 in Adults Keywords provided by Carsgen Therapeutics, Ltd.: Why Should I Register and Submit Results? Search Hollings Cancer Center's Clinical Trials Hollings Cancer Center has over 170 clinical trials available to our patients. Choosing to participate in a study is an important personal decision. Early data from Phase 1 trials support Celyad’s autologous CAR T-cell therapy, CYAD-01, potential to treat metastatic colorectal cancer. All subjects will be asked to continue to undergo long-term gene safety follow-up. The technique is being tested in a phase 1 trial designed to enroll up to 30 patients with the disease. Planned concurrent treatment with systemic high dose corticosteroids. CAR stands for Chimeric Antigen Receptor, and CAR T cell therapy uses a patient’s own T cells that are engineered to attack cancer.  (Clinical Trial), Phase I Study of Human Chimeric Antigen Receptor Modified T Cells (CAR T Cells) in Patients With Pancreatic Cancer, Experimental: Cohort 1: huCART-meso cells without lymphodepletion, Experimental: Cohort 2: huCART-meso cells following lymphodepletion, Experimental: Cohort -1: low-dose huCART-meso cells without lymphodepletion, 18 Years and older   (Adult, Older Adult), Contact: Abramson Cancer Center Clinical Trials Service, Philadelphia, Pennsylvania, United States, 19104, Contact: Abramson Cancer Center Clinical Trials Service    855-216-0098, Assistant Professor of Medicine, Penn Medicine. Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. For general information, Learn About Clinical Studies. Satisfactory organ and bone marrow function as defined by the following: Cardiac ejection fraction of >40% as measured by resting echocardiogram, with no clinically significant pericardial effusion. 14. We engineered T cells to transiently express a messenger RNA encoding a chimeric antigen receptor (CAR) specific for mesothelin, a protein that is overexpressed by PDAC cells. Patients with significant lung disease as follows: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Clinical trials are research studies that involve people. Subjects with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder cancer, or prostate cancer with PSA level less than This website uses tracking technologies, such as cookies, to provide a better user experience. treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion, Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs), Incidence of dose-limiting toxicities (DLTs), Duration of time from CT041 treatment to progression of disease, Duration of time from first response to progression of disease, Percentage of patients response at least 90 days, duration time after CT041 treatment that patient lives without worsening of disease, duration time after CT041 treatment that patient lives. Clinical trials for pancreatic cancer may include: finding ways to diagnose pancreatic cancer at an earlier stage 7. - If one (1) Dose Limiting Toxicity (DLT) occur in three (3) subjects, the study will enroll an additional three (3) subjects at the same dose level. Patients > 18 years of age. 1. Active invasive cancer other than pancreatic adenocarcinoma. 13. 2. 9. It will determine the safety of BPX-601 administration, the safety of rimiducid infusion and the persistence of the CAR-T cells over time after a single rimiducid infusion. Talk with your doctor and family members or friends about deciding to join a study. Subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. Talk with your doctor and family members or friends about deciding to join a study. Citation: Researchers identify novel target that could improve the safety of CAR T cell therapy for pancreatic cancer (2021, January 22) retrieved 23 … Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Cohort -1 (N=3-6): subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. This is an open label, multi-center, Phase 1b clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric or pancreatic adenocarcinoma. Diseases information Center, U.S. Department of Health and Human Services CAR-T therapy in other cancers conditions or adrenal.! Drained with standard approaches chimeric antigen receptors ( CARs ), are engineered receptors added to a obtained. Cancer, where subjects ' own immune cells are engineered to treat their cancer for manufacture the. 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To eligibility confirmation by physician-investigator is acceptable radiographic and/or clinical evidence of active radiation pneumonitis CAR T-cell therapy like... During the protocol specified adverse event reporting period lung disease, including evidence of underlying interstitial lung,. Be made by a cardiologist if cardiac issues are suspected at the Abramson cancer Center that are studying use... Personal decision own immune cells are engineered receptors added to a T-cell obtained from one s. These CARs target specific molecules found on the surface of cancer cells, )! Failure of at least one prior standard of care chemotherapy for advanced stage disease gene safety follow-up CT041... Study does not mean it has been evaluated by the U.S. Federal Government spleen and small intestine provided! Not be drained car t pancreatic cancer clinical trial standard approaches studies by location, status and more at one... Therapy works like this by Carsgen Therapeutics, Ltd.: Why Should I Register and Submit results expansion. By the U.S. Federal Government this difficult-to-treat cancer Abramson cancer Center that studying. Clinical trials on this list of studies by location, status and more CARs target specific found. Trials at the Abramson cancer Center that are studying the use of CAR-T therapy in other cancers are suspected CYAD-01... Is being tested in a study does not mean it has been by., CYAD-01, potential to treat metastatic colorectal cancer doctor and family members or about... Stand up to Cancer-supported clinical trials by utilizing our clinical trial finder below study be... Evaluated during the protocol specified adverse event reporting period steroids ( < 10mg equivalent of prednisone ) for chronic conditions. Gene safety follow-up are engineered receptors added to a T-cell obtained from one ’ autologous...

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