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. HIV infection 4. By rigging a patient’s own T cells into CAR T cells that problem is hopefully overcome. requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation by physician-investigator, with the exception of thyroid replacement. The technique is being tested in a phase 1 trial designed to enroll up to 30 patients with the disease. 7. Pancreatic Cancer Pipeline by Stages 2. For general information, Learn About Clinical Studies. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Failure of at least one prior standard of care chemotherapy for advanced stage disease. Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Bellicum’s shares are being routed after it announced a full house of horrors: poor data, a paused program and slashing the vast majority of its staff as it looks to save cash. 6. Study record managers: refer to the Data Element Definitions if submitting registration or results information. - 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. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. All trials available are categorized and can be … Phase 1 will include two parts, a dose escalation part to determine the recommended dose for the expansion part. Patients are eligible for screening for potential inclusion in the study: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Two doses (1-3 × 107/m2 and 1-3 × 108/m2) were infused (with or without prior cyclophosphamide) with a lymphodepleting regimen. At the CAR-TCR Summit held in Boston, the U.S. in Sep. 2018, the Chinese enterprise committed to developing CAR-T cell immunotherapy published the clinical data of its CAR-Claudin18.2 T-cell clinical trial in pancreatic/gastric T cells are the immune system cells that recognize and then destroy invaders, providing a line of defense against infections as well as cancers. Patients with radiographic and/or clinical evidence of active radiation pneumonitis. 5. 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. 16 studies in CAR-T Cell Therapy Program (open studies only). Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323944. Subjects must have measurable disease as defined by RECIST 1.1 criteria. Active hepatitis B or hepatitis C infection 5. Chimeric antigen receptors (CARs), are engineered receptors added to a T-cell obtained from one’s own blood. Pancreatic Cancer Clinical Trials A listing of Pancreatic Cancer medical research trials actively recruiting patient volunteers. A Study to Evaluate the Safety and Tolerability of KTE-X19 in Adults Early data from Phase 1 trials support Celyad’s autologous CAR T-cell therapy, CYAD-01, potential to treat metastatic colorectal 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. 1. 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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. They can also look at what causes pancreatic cancer, how to prevent it and find better ways to diagnose it. Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. Patients with ongoing or active infection. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Adverse events will be collected and evaluated during the protocol specified adverse event reporting period. 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. 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. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. 12. Clinical trials for pancreatic cancer are important because they show us what medicines and healthcare do and don’t work. Below are current clinical trials. COVID-19 is an emerging, rapidly evolving situation. Provides written informed consent. 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 Active autoimmune disease (including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) The mean number of … 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. 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. Part A of the study will be Dose Escalation followed by … This website uses tracking technologies, such as cookies, to provide a better user experience. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc). To learn more, search our clinical trials . Citation: Researchers identify novel target that could improve the safety of CAR T cell therapy for pancreatic cancer (2021, January 22) retrieved 23 … Active invasive cancer other than pancreatic adenocarcinoma. 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. 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. Up to six (6) subjects will be infused in Cohort -1 with not more than one (1) DLT occurring in six (6) subjects to establish the Maximum Tolerated Dose (MTD). 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. 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. The trial will take place at Baylor University Medical Center in Dallas. For general information, Learn About Clinical Studies. 2.  (Clinical Trial), Open-label, Multicenter, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous Claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma, Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy, 18 Years to 80 Years   (Adult, Older Adult), San Diego, California, United States, 92093, Rochester, Minnesota, United States, 55905, TX Oncology-Baylor Charles Sammons Cancer Center. 9. 14. 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. Prior therapy with lentiviral gene modified cells. Choosing to participate in a study is an important personal decision. 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.  (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. Least one prior standard of care chemotherapy for advanced stage disease submitting registration results... 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