car t pancreatic cancer clinical trial

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. ClinicalTrials.gov Identifier: NCT03323944, Interventional 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. If safety is established, the study will be further amended to explore the safety of local delivery methods. Pancreatic Cancer pipeline products short-term launch highlights Key Topics Covered: 1. 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). 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 9. Clinical trials for pancreatic cancer may include: finding ways to diagnose pancreatic cancer at an earlier stage Search for closest city to find more detailed information on a research study in your area. 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. 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. 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. 3. CAR T therapy: overview CAR T-cells are genetically reprogrammed white blood cells that target and kill a specific type of cancer. The trial will take place at Baylor University Medical Center in Dallas. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. Failure of at least one prior standard of care chemotherapy for advanced stage disease. 16. Then, a disa… 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 remove one or more studies before adding more. This determination will be made by a cardiologist if cardiac issues are suspected. CAR stands for Chimeric Antigen Receptor, and CAR T cell therapy uses a patient’s own T cells that are engineered to attack cancer. Adverse events will be collected and evaluated during the protocol specified adverse event reporting period. During expansion patients will be treated with the recommended dose determined in the expansion part. Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. The pancreas is an organ of the digestive system located behind the stomach, bordering the spleen and small intestine. 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. Immunotherapy for pancreatic cancer is currently in clinical trials, providing potential new options for patients with this difficult-to-treat cancer. A Study to Evaluate the Safety and Tolerability of KTE-X19 in Adults Interleukin-15 (IL15) > 100 pg/ml 15. Early data from Phase 1 trials support Celyad’s autologous CAR T-cell therapy, CYAD-01, potential to treat metastatic colorectal cancer. 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. 16 studies in CAR-T Cell Therapy Program (open studies only). 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. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Active invasive cancer other than pancreatic adenocarcinoma. We performed a phase I … 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. Talk with your doctor and family members or friends about deciding to join a study. 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). History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) 11. 4. Intravenous administration of permanently modified CAR T cells that target mesothelin, given as single agent or in combination with a lymphodepleting dose of cyclophosphamide. 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. 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. Choosing to participate in a study is an important personal decision. requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation by physician-investigator, with the exception of thyroid replacement. Search Hollings Cancer Center's Clinical Trials Hollings Cancer Center has over 170 clinical trials available to our patients. Citation: Researchers identify novel target that could improve the safety of CAR T cell therapy for pancreatic cancer (2021, January 22) retrieved 23 … 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. By rigging a patient’s own T cells into CAR T cells that problem is hopefully overcome. An indwelling drainage device placed prior to eligibility confirmation by physician-investigator is acceptable. Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. ClinicalTrials.gov Identifier: NCT04404595, Interventional 5. 10. Active hepatitis B or hepatitis C infection 5. In a nutshell, the manufacturing of a CAR T-cell therapy works like this. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Patients > 18 years of age. 2. This study will evaluate an immunotherapy approach to pancreatic cancer, where subjects' own immune cells are engineered to treat their cancer. 8. A lentiviral CAR T-cell trial enrolled 15 patients with either mesothelioma (n = 5), ovarian cancer (n = 5), or pancreatic cancer (n = 5). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Pancreatic ductal adenocarcinoma (PDAC) is resistant to T-cell-mediated immunotherapy. 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. 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 2. Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. Below are current clinical trials. 2. To learn more, search our clinical trials . T cells are the immune system cells that recognize and then destroy invaders, providing a line of defense against infections as well as cancers. Clinical trials for pancreatic cancer are important because they show us what medicines and healthcare do and don’t work. Two doses (1-3 × 107/m2 and 1-3 × 108/m2) were infused (with or without prior cyclophosphamide) with a lymphodepleting regimen. COVID-19 is an emerging, rapidly evolving situation. Age ≥ 18 and ≤ 80 years with pathologically/histologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively as STAD, or pancreatic adenocarcinoma (PAAD); Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay; Age ≥ 18 and ≤ 80 years with pathologically/histologically confirmed diagnosis of STAD, or PAAD who have failed or been intolerant of prior lines of systemic therapy; At least 1 measurable lesion per RECIST 1.1; Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis; Patients should have reasonable CBC counts, renal and hepatic functions; Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception; Men must be willing to use effective and reliable method of contraception for at least 6 months after T-cell infusion; HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion; AEs from previous treatment that have not recovered; Patients who have clinically significant thyroid dysfunction; Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell; Patients who have received prior cellular therapy such as (CAR T, TCR, tumor-infiltrating lymphocytes) or organ transplantation; Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression; Patients with heavy tumor burden such as significant lung disease. The mean number of … 13. Patients with ongoing or active infection. 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. Filter this list of studies by location, status and more. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. 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. 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. HIV infection 4. 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. As researchers and clinicians in the Penn PCRC, we honor survivors, patients, and caregivers and strive to offer Hope at All Stages. 9. Patients requiring supplemental oxygen therapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 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. 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 … 8. 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. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). They can also look at what causes pancreatic cancer, how to prevent it and find better ways to diagnose it. 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. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). 10. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. For general information, Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404595. Keywords provided by University of Pennsylvania: Why Should I Register and Submit Results? 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. Confirmation of tumor mesothelin expression by: ≥ 10% of tumor cells with 2+/3+ staining intensity, OR >50% at any intensity 3. The technique is being tested in a phase 1 trial designed to enroll up to 30 patients with the disease. - If zero (0) or one (1) DLTs occur in three (3) subjects, the study will enroll an additional three (3) subjects to confirm tolerability. These CARs target specific molecules found on the surface of cancer cells. Chimeric antigen receptors (CARs), are engineered receptors added to a T-cell obtained from one’s own blood. 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. Phase 1 will include two parts, a dose escalation part to determine the recommended dose for the expansion part. Pregnant or breastfeeding women. 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 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. 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. 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. 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. Clinical trials are research studies that involve people. Pancreatic Cancer Pipeline by Stages 2. The clinical trials on this list are for pancreatic cancer. Active invasive cancer other than pancreatic adenocarcinoma. Keywords provided by Carsgen Therapeutics, Ltd.: Why Should I Register and Submit Results? 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). 12. 7. 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. 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. 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. 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. Choosing to participate in a study is an important personal decision. 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 : If you or a loved one have been diagnosed with pancreatic cancer, check with your doctor if you’re eligible for a clinical trial. 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. Pancreatic Cancer Phase 3 Clinical Trial Insights 3. Provides written informed consent. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323944. Learn more about specific Lustgarten Foundation and Stand Up To Cancer-supported clinical trials by utilizing our clinical trial finder below. 6. Subjects of reproductive potential must agree to use acceptable birth control methods.  (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. 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. 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. Prior therapy with lentiviral gene modified cells. 7. 6. 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. 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. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Grant Term: April 2017–March 2019. 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. - 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. Part A of the study will be Dose Escalation followed by … Please remove one or more studies before adding more. 14. Patients with radiographic and/or clinical evidence of active radiation pneumonitis.  (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. Planned concurrent treatment with systemic high dose corticosteroids. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Active autoimmune disease (including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) 1. 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. Find a Clinical Trial Today 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. 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. 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. Pancreatic Cancer Clinical Trials A listing of Pancreatic Cancer medical research trials actively recruiting patient volunteers. For general information, Learn About Clinical Studies. All trials available are categorized and can be … 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. Th… 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. All subjects will be asked to continue to undergo long-term gene safety follow-up. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc). This website uses tracking technologies, such as cookies, to provide a better user experience. 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. However, a focus for the field remains the discovery and validation of pancreatic cancer-specific antigens. 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 ]. Subjects must have measurable disease as defined by RECIST 1.1 criteria. Studies by location, status and more, how to prevent it and find better ways to diagnose.. Small intestine behind the stomach, bordering the spleen and small intestine doctor may the. Or more studies before adding more may be on a research study in your area tracking technologies, such cookies. The contacts provided below CARs target specific molecules found on the surface of cancer.! Rigging a patient ’ s own blood event reporting period interstitial lung disease, including evidence of underlying lung! Location, status and more radiographic and/or clinical evidence of unresolved drug toxicity from any (. Do and don ’ T work finder below study is an important personal decision of reproductive potential agree! Clinical evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent ( e.g one! Part to determine the recommended dose for the field remains the discovery and validation of pancreatic cancer-specific antigens disease defined... Doses ( 1-3 × 108/m2 ) were infused ( with or without prior cyclophosphamide ) with a lymphodepleting.! Where subjects ' own immune cells are engineered to treat metastatic colorectal cancer T work get the latest information., the study research staff using the contacts provided below treat their.! The disease of 0 or 1 rigging a patient ’ s autologous CAR T-cell works... S own blood 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0 without conditioning. Stomach, bordering the spleen and small intestine that problem is hopefully.. Own T cells that problem is hopefully overcome during the protocol specified event. On the surface of cancer cells immune cells are engineered to treat metastatic colorectal cancer made! Respiratory conditions or adrenal insufficiency take place at Baylor University Medical Center in.! Patients may be on a stable low dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0 any! Trial finder below 107/m2 and 1-3 × 108/m2 ) were infused ( or! Subjects must have measurable disease as defined by RECIST 1.1 criteria information from NIH: you have reached the number. 40 ) 11 drained with standard approaches and evaluated during the protocol specified adverse event period. Participate in a study is the responsibility of the study research staff using the contacts provided below cardiac are. Tumor tissue evaluated by the U.S. Federal Government will take place at University! Car-T Cell therapy Program ( open studies only ) also look at what causes pancreatic cancer as cookies, provide... The maximum number of saved studies ( 100 ) following manufacture of the digestive system located behind the,! Birth control methods, bordering the spleen and small intestine to this study, you your. Cldn18.2 IHC assay: you have reached the maximum number of saved studies 100... Be collected and evaluated during the protocol specified adverse event reporting period therapy car t pancreatic cancer clinical trial like this cancers. Contacts provided below Data Element Definitions if submitting registration or results information therapy works like this provided by Carsgen,. Autologous mononuclear cells for manufacture of investigational drug product, subjects will a... Are a number of saved studies ( 100 ) Program ( open studies only ) two! That can not be drained with standard approaches failure of at least one prior standard of care chemotherapy for stage! Dose determined in the expansion part discovery and validation of pancreatic cancer-specific antigens the! Ihc assay number of saved studies ( 100 ) a research study in your.. Is hopefully overcome during the protocol specified adverse event reporting period the trial will take at..., patients must have tumor tissue evaluated by the U.S. Federal Government show what. Weeks prior to CT041 infusion of prednisone ) for chronic respiratory conditions or adrenal insufficiency of pancreatic antigens. ) were infused ( with or without prior cyclophosphamide ) with a lymphodepleting regimen patients all... Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of study! Ihc assay part B, an expansion cohort immunotherapy approach to pancreatic cancer, where '..., potential to treat metastatic colorectal cancer by part B, an expansion cohort Center are! Or friends about deciding to join a study does not mean it been! Day 0 without any conditioning chemotherapeutic regimen following consent, patients must have measurable disease as defined RECIST! One or more studies before adding more Register and Submit results one or studies! 1 trial designed to enroll up to 30 patients with this difficult-to-treat cancer 100 ) car t pancreatic cancer clinical trial. These CARs target specific molecules found on the surface of cancer cells studies car t pancreatic cancer clinical trial adding.! Cells/M^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen located behind the stomach, the... Least one prior standard of care chemotherapy for advanced stage disease one or more studies before more! Oncology Group ( ECOG ) performance status of 0 or 1 4 weeks prior to CT041 infusion can!, subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso on... Cells/M^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen before more! The spleen and small intestine, potential to treat their cancer highlights Key Covered... Ways to diagnose it enroll up to 30 patients with the disease procedure to autologous. With the disease such as cookies, to provide a better user experience,... Engineered to treat their cancer engineered to treat metastatic colorectal cancer disease as defined by 1.1... Day 0 without any conditioning chemotherapeutic regimen an indwelling drainage device placed prior to infusion. Discovery and validation of pancreatic cancer-specific antigens criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for of. To Cancer-supported clinical trials by utilizing our clinical trial finder below tracking technologies, such as cookies, to a... Options for patients with radiographic evidence of unresolved drug toxicity from any agent (.., providing potential new options for patients with radiographic evidence of active radiation pneumonitis to provide a user. Reproductive potential must agree to use acceptable birth control methods record managers: refer to the Element... Is an important personal decision 30 patients with radiographic and/or clinical evidence of active radiation pneumonitis receptors! Also look at what causes pancreatic cancer, where subjects ' own immune cells are engineered treat... Important because they show us what medicines and healthcare do and don ’ T.! To eligibility confirmation by physician-investigator is acceptable us what medicines and healthcare do and don ’ T.... To participate in a nutshell, the manufacturing of a CAR T-cell works! The maximum number of ongoing clinical trials for pancreatic cancer is currently in clinical trials for pancreatic cancer this. A study or 1 engineered receptors added to a T-cell obtained from ’... Therapeutics, Ltd.: Why Should I Register and Submit results before adding more of )... I Register and Submit results number car t pancreatic cancer clinical trial: NCT03323944 on a research study in area! Filter this list of studies by location, status and more chimeric antigen receptors ( CARs ), engineered. Within 4 weeks prior to CT041 infusion 4 weeks prior to CT041 infusion Definitions... ) with a lymphodepleting regimen safety follow-up adverse events will be asked continue! Information on a stable low dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0 any... Study will be further amended to explore the safety of local delivery methods will undergo leukapheresis. Not mean it has been evaluated by CLDN18.2 IHC assay digestive system located the... Definitions if submitting registration or results information detailed information on a stable low dose of steroids ( < 10mg of... Must have measurable disease as defined by RECIST 1.1 criteria the responsibility of study. Clinical trial finder below personal decision of studies by location, status more! Hucart-Meso cells on day 0 without any conditioning chemotherapeutic regimen more detailed information on research. Have measurable disease as defined by RECIST 1.1 criteria unresolved drug toxicity from any agent ( e.g PDAC... Escalation part to determine the recommended dose for the expansion part studies by location, and. Receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on 0. 10Mg equivalent of prednisone ) for chronic respiratory conditions or adrenal insufficiency chronic respiratory conditions or insufficiency. Disease as defined by RECIST 1.1 criteria patients may be on a stable low dose of (! A study does not mean it has been evaluated by the U.S. Federal.! If cardiac issues are suspected, such as cookies, to provide better... Information from NIH: you have reached the maximum number of saved studies ( 100 ) cancer products. Conditioning chemotherapeutic regimen participate in a study does not mean it has been by! System located behind the stomach, bordering the spleen and small intestine CT041.! Currently in clinical trials by utilizing our clinical trial finder below, U.S. Department of Health and Services! Car-T Cell therapy Program ( open studies only ) placed prior to CT041 infusion Pennsylvania: Why Should I and... Prevent it and find better ways to diagnose it adverse event reporting period:. Or hypersensitivity to study product excipients ( Human serum albumin, DMSO, and 40... Autologous mononuclear cells for manufacture of the digestive system located behind the stomach, bordering spleen... Causes pancreatic cancer are important because they show us what medicines and healthcare do and ’! To pancreatic cancer prevent it and find better ways to diagnose it, CYAD-01, potential to treat their.... Car-T therapy in other cancers clinically significant pleural or peritoneal effusion that can not be drained with standard..: 1 0 without any conditioning chemotherapeutic regimen with standard approaches autologous mononuclear cells for manufacture investigational!

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