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 … All trials available are categorized and can be … Choosing to participate in a study is an important personal decision. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. 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. 8. As researchers and clinicians in the Penn PCRC, we honor survivors, patients, and caregivers and strive to offer Hope at All Stages. requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation by physician-investigator, with the exception of thyroid replacement. Planned concurrent treatment with systemic high dose corticosteroids. 7. Search for closest city to find more detailed information on a research study in your area. 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. 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. 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. Subjects of reproductive potential must agree to use acceptable birth control methods. 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. The clinical trials on this list are for pancreatic cancer. 14. 2. 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. Below are current clinical trials. All subjects will be asked to continue to undergo long-term gene safety follow-up. 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. 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. 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. Part A of the study will be Dose Escalation followed by … Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. 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). Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. 12. Immunotherapy for pancreatic cancer is currently in clinical trials, providing potential new options for patients with this difficult-to-treat cancer. Please remove one or more studies before adding more. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder cancer, or prostate cancer with PSA level < 1.0) are not excluded. 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 ]. Adverse events will be collected and evaluated during the protocol specified adverse event reporting period. Early data from Phase 1 trials support Celyad’s autologous CAR T-cell therapy, CYAD-01, potential to treat metastatic colorectal cancer. 10. 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. This determination will be made by a cardiologist if cardiac issues are suspected. A lentiviral CAR T-cell trial enrolled 15 patients with either mesothelioma (n = 5), ovarian cancer (n = 5), or pancreatic cancer (n = 5). Confirmation of tumor mesothelin expression by: ≥ 10% of tumor cells with 2+/3+ staining intensity, OR >50% at any intensity 3. - If zero (0) or one (1) DLTs occur in three (3) subjects, the study will enroll an additional three (3) subjects to confirm tolerability. 7. Once the collected white blood cells are in hand, research groups use various methods to isolate specific T cells from the other white blood cells. For general information, Learn About Clinical Studies. 13. An indwelling drainage device placed prior to eligibility confirmation by physician-investigator is acceptable. 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. The technique is being tested in a phase 1 trial designed to enroll up to 30 patients with the disease. 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. T cells are the immune system cells that recognize and then destroy invaders, providing a line of defense against infections as well as cancers. ClinicalTrials.gov Identifier: NCT04404595, Interventional 3. 2. For general information, Learn About Clinical Studies. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. Filter this list of studies by location, status and more. 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. 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. 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. Subjects must have measurable disease as defined by RECIST 1.1 criteria. 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. 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. Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Active invasive cancer other than pancreatic adenocarcinoma. 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Search Hollings Cancer Center's Clinical Trials Hollings Cancer Center has over 170 clinical trials available to our patients. 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. Pancreatic Cancer pipeline products short-term launch highlights Key Topics Covered: 1. 5. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc). 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. Pancreatic Cancer Phase 3 Clinical Trial Insights 3. 1. However, if two (2) DLTs occur at this dose level at any time, enrollment in Cohort 1 will be stopped, and the administered dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2, and enrollment into Cohort -1 will begin. Find a Clinical Trial Today 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. By rigging a patient’s own T cells into CAR T cells that problem is hopefully overcome. 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. 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 : Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) 11. 4. During expansion patients will be treated with the recommended dose determined in the expansion part. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323944. If you or a loved one have been diagnosed with pancreatic cancer, check with your doctor if you’re eligible for a clinical trial. HIV infection 4. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Active autoimmune disease (including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) 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? Intravenous administration of permanently modified CAR T cells that target mesothelin, given as single agent or in combination with a lymphodepleting dose of cyclophosphamide. Clinical trials for pancreatic cancer are important because they show us what medicines and healthcare do and don’t work. However, a focus for the field remains the discovery and validation of pancreatic cancer-specific antigens. The pancreas is an organ of the digestive system located behind the stomach, bordering the spleen and small intestine. Chimeric antigen receptors (CARs), are engineered receptors added to a T-cell obtained from one’s own blood. Interleukin-15 (IL15) > 100 pg/ml 15. 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 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. 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. 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. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. 9. Pregnant or breastfeeding women. 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. 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 Clinical trials are research studies that involve people. Pancreatic ductal adenocarcinoma (PDAC) is resistant to T-cell-mediated immunotherapy. Two doses (1-3 × 107/m2 and 1-3 × 108/m2) were infused (with or without prior cyclophosphamide) with a lymphodepleting regimen. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404595. Choosing to participate in a study is an important personal decision. Learn more about specific Lustgarten Foundation and Stand Up To Cancer-supported clinical trials by utilizing our clinical trial finder below. 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. Clinical trials for pancreatic cancer may include: finding ways to diagnose pancreatic cancer at an earlier stage Citation: Researchers identify novel target that could improve the safety of CAR T cell therapy for pancreatic cancer (2021, January 22) retrieved 23 … 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. Active invasive cancer other than pancreatic adenocarcinoma. 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. 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). - 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. 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. 9. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This study will evaluate an immunotherapy approach to pancreatic cancer, where subjects' own immune cells are engineered to treat their cancer. COVID-19 is an emerging, rapidly evolving situation. Patients with radiographic and/or clinical evidence of active radiation pneumonitis. Patients with ongoing or active infection.  (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.  (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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 10. These CARs target specific molecules found on the surface of cancer cells. Then, a disa… Patients > 18 years of age. 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. Pancreatic Cancer Clinical Trials A listing of Pancreatic Cancer medical research trials actively recruiting patient volunteers. Any clinically significant pleural or peritoneal effusion that can not be drained with approaches! Control methods, you or your doctor may contact the study will evaluate immunotherapy! Are a number of saved studies ( 100 ) of care chemotherapy for advanced disease... 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