If two (2) DLTs occur in three (3) subjects or two (2) DLTs occur in six (6) subjects, further infusions in this cohort will be halted. Provides written informed consent. They can also look at what causes pancreatic cancer, how to prevent it and find better ways to diagnose it. If safety is established, the study will be further amended to explore the safety of local delivery methods. Pancreatic ductal adenocarcinoma (PDAC) is resistant to T-cell-mediated immunotherapy. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Confirmation of tumor mesothelin expression by: ≥ 10% of tumor cells with 2+/3+ staining intensity, OR >50% at any intensity 3. In addition to advances involving CAR T cell therapy and vaccines, a CRI-funded trial revealed the promise of a novel immunotherapy-chemotherapy combination in advanced pancreatic cancer. Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. Clinical trials for pancreatic cancer are important because they show us what medicines and healthcare do and don’t work. 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. Phase 1 will include two parts, a dose escalation part to determine the recommended dose for the expansion part. This is a Phase I study evaluating the feasibility of producing as well as the safety of administering lentiviral transduced huCART-meso cells in up to three (3) cohorts both with and without cyclophosphamide in a three-plus-three (3+3) dose escalation design. 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 … CAR T therapy, a therapeutic strategy to use the patient’s immune cells to fight cancer, has been promising with blood cancers but seems less effective in treating solid cancers. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. CAR T therapy: overview CAR T-cells are genetically reprogrammed white blood cells that target and kill a specific type of cancer. 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. 8. 7. We performed a phase I … Cohort 1(N=3-6): subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. CAR-CLDN18.2 (CARsgen Therapeutics) targets claudin 18.2, a stomach-specific isoform of claudin-18 that is highly expressed in gastric and pancreatic adenocarcinomas. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). COVID-19 is an emerging, rapidly evolving situation. All trials on the list are supported by NCI.NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. In a nutshell, the manufacturing of a CAR T-cell therapy works like this. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. Phase I Study of Human Chimeric Antigen Receptor Modified T Cells (CAR T Cells) in Patients With Pancreatic Cancer Actual Study Start Date : September 15, 2017 Estimated Primary Completion Date : September 2021 : Using this protein as a target, the team successfully created a CAR T cell therapy - a type of immunotherapy - that killed pancreatic cancer cells in a pre-clinical model. - If zero (0) or one (1) DLTs occur in three (3) subjects, the study will enroll an additional three (3) subjects to confirm tolerability. Marker today announced interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine, evaluating the Company’s MultiTAA T cell therapy in patients with pancreatic adenocarcinoma. 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. 2. 8. Pancreatic Cancer pipeline products short-term launch highlights Key Topics Covered: 1. Li and colleagues conducted a first-in-human, open-label, single-arm, phase 1 clinical trial to evaluate autologous CAR-CLDN18.2 T cells in patients with advanced gastric or pancreatic cancer whose tumors expressed … All trials available are categorized and can be … 10. An indwelling drainage device placed prior to eligibility confirmation by physician-investigator is acceptable. Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. 9. Talk with your doctor and family members or friends about deciding to join a study. Please remove one or more studies before adding more. 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. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. 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. HIV infection 4. 12. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. All subjects will be asked to continue to undergo long-term gene safety follow-up. Talk with your doctor and family members or friends about deciding to join a study. 13. The pancreas is an organ of the digestive system located behind the stomach, bordering the spleen and small intestine. Active autoimmune disease (including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) 14. 4. 5. - 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. 2. Then, a disa… There are a number of ongoing clinical trials at the Abramson Cancer Center that are studying the use of CAR-T therapy in other cancers. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Incidence of Treatment Related adverse events (AEs) [ Time Frame: day 1 - month 12 ], Identification of Maximum Tolerated Dose (MTD) [ Time Frame: day 1 - month 12 ], Time to Progression [ Time Frame: day 1 - month 12 ], Duration of Response [ Time Frame: day 1 - month 12 ], Disease Control Rate [ Time Frame: day 1 - month 12 ], Progression free survival [ Time Frame: day 1 - month 12 ], Overall survival [ Time Frame: day 1 - month 12 ]. Citation: Researchers identify novel target that could improve the safety of CAR T cell therapy for pancreatic cancer (2021, January 22) retrieved 23 … Cohort 2 (N=3-6): subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 following a flat dose of 1 gram/m^2 of cyclophosphamide administered 2-4 days prior to huCART-meso cells (~day -4 to day -2). chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc). Two doses (1-3 × 107/m2 and 1-3 × 108/m2) were infused (with or without prior cyclophosphamide) with a lymphodepleting regimen. CAR T cell Therapies in Treating Pancreatic Cancer In recent years, CAR T cell therapies have been tested in both preclinical and clinical settings for treating pancreatic cancers. Patients requiring supplemental oxygen therapy. Please remove one or more studies before adding more. Chimeric antigen receptors (CARs), are engineered receptors added to a T-cell obtained from one’s own blood. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) 11. Pancreatic Cancer Clinical Trials A listing of Pancreatic Cancer medical research trials actively recruiting patient volunteers. 6. Early data from Phase 1 trials support Celyad’s autologous CAR T-cell therapy, CYAD-01, potential to treat metastatic colorectal cancer. Pancreatic Cancer Pipeline by Stages 2. In the phase 1 clinical trial (NCT04050709), researchers tested the safety and preliminary efficacy of this treatment strategy in a patient with second-line metastatic pancreatic cancer, meaning that the combination therapy of PD-L1-targeted NK cells and N-803 was used as a secondary treatment after relapse following a previous standard-of-care therapy. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323944. This study will evaluate an immunotherapy approach to pancreatic cancer, where subjects' own immune cells are engineered to treat their cancer. Patients with radiographic and/or clinical evidence of active radiation pneumonitis. Grant Term: April 2017–March 2019. 7. 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). Treatment with a PD-1 or PD-L1 inhibitor, including but not limited to nivolumab, pembrolizumab, atezolizumab, and/or durvalumab, within 2 months prior to eligibility confirmation by investigator. Pancreatic Cancer Phase 3 Clinical Trial Insights 3. 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. Therapy, CYAD-01, potential to treat metastatic colorectal cancer criteria will undergo a leukapheresis procedure to collect autologous cells... Their cancer receive preconditioning prior to eligibility confirmation by physician-investigator is acceptable stomach, bordering the spleen and small.... Immunotherapy approach to pancreatic cancer, where subjects ' own immune cells are engineered to treat their cancer remains discovery! 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