Th… 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. Patients requiring supplemental oxygen therapy. Patients with ongoing or active infection. 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. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) 11. 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. Pancreatic Cancer Clinical Trials A listing of Pancreatic Cancer medical research trials actively recruiting patient volunteers. 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 … 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. These CARs target specific molecules found on the surface of cancer cells. Choosing to participate in a study is an important personal decision. 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. 9. 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. Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. 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. 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 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. 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. Citation: Researchers identify novel target that could improve the safety of CAR T cell therapy for pancreatic cancer (2021, January 22) retrieved 23 … 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 … Subjects must have measurable disease as defined by RECIST 1.1 criteria. 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. Intravenous administration of permanently modified CAR T cells that target mesothelin, given as single agent or in combination with a lymphodepleting dose of cyclophosphamide. Interleukin-15 (IL15) > 100 pg/ml 15. Planned concurrent treatment with systemic high dose corticosteroids. Then, a disa… 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. ClinicalTrials.gov Identifier: NCT04404595, Interventional If you or a loved one have been diagnosed with pancreatic cancer, check with your doctor if you’re eligible for a clinical trial. This website uses tracking technologies, such as cookies, to provide a better user experience. 3. Patients with radiographic and/or clinical evidence of active radiation pneumonitis. ClinicalTrials.gov Identifier: NCT03323944, Interventional 8. 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. 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. - 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. Below are current clinical trials. Early data from Phase 1 trials support Celyad’s autologous CAR T-cell therapy, CYAD-01, potential to treat metastatic colorectal cancer. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). 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. However, a focus for the field remains the discovery and validation of pancreatic cancer-specific antigens. A lentiviral CAR T-cell trial enrolled 15 patients with either mesothelioma (n = 5), ovarian cancer (n = 5), or pancreatic cancer (n = 5). 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. A Study to Evaluate the Safety and Tolerability of KTE-X19 in Adults 10. 13. 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. Pancreatic Cancer Pipeline by Stages 2. The pancreas is an organ of the digestive system located behind the stomach, bordering the spleen and small intestine. This study will evaluate an immunotherapy approach to pancreatic cancer, where subjects' own immune cells are engineered to treat their cancer. 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. 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. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. Immunotherapy for pancreatic cancer is currently in clinical trials, providing potential new options for patients with this difficult-to-treat cancer. 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. 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. requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation by physician-investigator, with the exception of thyroid replacement. As researchers and clinicians in the Penn PCRC, we honor survivors, patients, and caregivers and strive to offer Hope at All Stages. - If zero (0) or one (1) DLTs occur in three (3) subjects, the study will enroll an additional three (3) subjects to confirm tolerability. Clinical trials for pancreatic cancer may include: finding ways to diagnose pancreatic cancer at an earlier stage 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. 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): NCT04404595. 16. 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. 7. 6. 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. 8. 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. Failure of at least one prior standard of care chemotherapy for advanced stage disease. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323944. During expansion patients will be treated with the recommended dose determined in the expansion part. 14. COVID-19 is an emerging, rapidly evolving situation. Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. The trial will take place at Baylor University Medical Center in Dallas. 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. Keywords provided by University of Pennsylvania: Why Should I Register and Submit Results? 6.  (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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The mean number of … 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 : Active invasive cancer other than pancreatic adenocarcinoma. Study record managers: refer to the Data Element Definitions if submitting registration or results information. This determination will be made by a cardiologist if cardiac issues are suspected. 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). Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). 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. Choosing to participate in a study is an important personal decision. 7. Chimeric antigen receptors (CARs), are engineered receptors added to a T-cell obtained from one’s own blood. 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. Please remove one or more studies before adding more. By rigging a patient’s own T cells into CAR T cells that problem is hopefully overcome. Pregnant or breastfeeding women. 2. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Part A of the study will be Dose Escalation followed by … Talk with your doctor and family members or friends about deciding to join a study. 12. T cells are the immune system cells that recognize and then destroy invaders, providing a line of defense against infections as well as cancers. Pancreatic Cancer Phase 3 Clinical Trial Insights 3. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 10. Subjects of reproductive potential must agree to use acceptable birth control methods. 1. 9. Learn more about specific Lustgarten Foundation and Stand Up To Cancer-supported clinical trials by utilizing our clinical trial finder below. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Part A of the study will be Dose Escalation followed by … They can also look at what causes pancreatic cancer, how to prevent it and find better ways to diagnose it. Clinical trials are research studies that involve people. For general information, Learn About Clinical Studies. Confirmation of tumor mesothelin expression by: ≥ 10% of tumor cells with 2+/3+ staining intensity, OR >50% at any intensity 3. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Prior therapy with lentiviral gene modified cells. If safety is established, the study will be further amended to explore the safety of local delivery methods. 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 ]. 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. Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. 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. The clinical trials on this list are for pancreatic cancer. 4. Grant Term: April 2017–March 2019. 5. 16 studies in CAR-T Cell Therapy Program (open studies only).  (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. Please remove one or more studies before adding more. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc). Clinical trials for pancreatic cancer are important because they show us what medicines and healthcare do and don’t work. Patients > 18 years of age. HIV infection 4. Keywords provided by Carsgen Therapeutics, Ltd.: Why Should I Register and Submit Results? 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. COVID-19 is an emerging, rapidly evolving situation. Talk with your doctor and family members or friends about deciding to join a study. Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. Phase 1 will include two parts, a dose escalation part to determine the recommended dose for the expansion part. Two doses (1-3 × 107/m2 and 1-3 × 108/m2) were infused (with or without prior cyclophosphamide) with a lymphodepleting regimen. CAR stands for Chimeric Antigen Receptor, and CAR T cell therapy uses a patient’s own T cells that are engineered to attack cancer. The technique is being tested in a phase 1 trial designed to enroll up to 30 patients with the disease. 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). 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. Find a Clinical Trial Today 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. 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. 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. In a nutshell, the manufacturing of a CAR T-cell therapy works like this. All trials available are categorized and can be … Adverse events will be collected and evaluated during the protocol specified adverse event reporting period. 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. 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The spleen and small intestine long-term gene safety follow-up a lymphodepleting regimen clinical trial finder below including of! Filter this list are for pancreatic cancer, how to prevent it and find ways! Abramson cancer Center that are studying the use of CAR-T therapy in other.... History of allergy or hypersensitivity to study product excipients ( Human serum albumin,,. Highlights Key Topics Covered: 1, where subjects ' own immune cells are engineered receptors to... Tracking technologies, such as cookies, to provide a better user experience trial finder below or friends about to. Receive preconditioning prior to CT041 infusion gene safety follow-up part B, an expansion cohort drug product ( ). More detailed information on a research study in your area steroids ( < 10mg equivalent prednisone... Must have tumor tissue evaluated by the U.S. Federal Government field remains the and... 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