View clinical trials related to Neoplasms.
Filter by:This is an open-label, multicenter, dose escalation and expansion phase I /II study of IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size is 46. One or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. In order to get them to kill cancers more effectively, in the laboratory, the study team inserted a new gene called a chimeric antigen receptor (CAR) into T cells that makes them recognize cancer cells and kill them. When inserted, this new CAR T cell can specifically recognize a protein found on solid tumors, called glypican-3 (GPC3). To make this GPC3-CAR more effective, the study team also added two genes called IL15 and IL21 that help CAR T cells grow better and stay in the blood longer so that they may kill tumors better. When the study team did this in the laboratory, they found that this mixture of GPC3-CAR,IL15 and IL21 killed tumor cells better when compared with CAR T cells that did not have IL15 plus IL21 in the laboratory. This study will use those cells, which are called 21.15.GPC3-CAR T cells, to treat patients with solid tumors that have GPC3 on their surface. The study team also wanted to make sure that they could stop the 21.15.GPC3-CAR T cells from growing in the blood should there be any bad side effects. In order to do so, they inserted a gene called iCasp9 into the FAST-CAR T cells. This allows us the elimination of 21.15.GPC3-CAR T cells in the blood when the gene comes into contact with a medication called AP1903. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. This drug will only be used to kill the T cells if necessary due to side effects . The study team has treated patients with T cells that include GPC3. Patients have also been treated with IL-21 and with IL-15. Patients have not been treated with a combination of T cells that contain GPC3, IL-21 and IL-15. To summarize, this study will test the effect of 21.15.GPC3-CAR T cells in patients with solid tumors that express GPC3 on their surface. The 21.15.GPC3-CAR T cells are an investigational product not yet approved by the Food and Drug Administration.
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.
Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.
This is a single-arm, open-label, multicenter, phase II study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency. It is planned to enroll patients with PTEN deficiency advanced solid tumors of different tumor types (PTEN deficiency gastric cancer, prostate cancer, endometrial cancer, colorectal cancer, lung cancer, breast cancer and melanoma etc.) to evaluate the preliminary efficacy, safety and pharmacokinetic profile of CVL237 tablets in patients with PTEN deficiency advanced solid tumors of different tumor types.
Since the discovery that Treg suppress anti-tumor immune responses, inhibiting their function has become a major challenge for the development of efficient immunotherapy for cancer. In humans, we previously reported the positive results of a first clinical trial using Treg depletion for anti-tumor response amplification in the field of allogeneic hematopoietic stem cell transplantation (HSCT). The present project aims at developing this anti-tumor immunotherapeutic strategy in the same setting, i.e. donor lymphocyte infusion (DLI) for relapsing hematological malignancies after HSCT, using a new selection marker: CD127. The choice of this new strategy is supported by our results of a retrospective clinical study and pre-clinical data. Using human cells, this studies demonstrated, in vitro and in vivo in animal murine models, that Treg depletion through CD127 positive selection is much more efficient to improve allogeneic immune responses of donor T-cells as compared to the previous strategy using the CD25 marker.
BCR:ABL1 negative myeloproliferative neoplasms (MPN) include three entities: polycythemia vera, essential thrombocythemia and primitive myelofibrosis. Myelofibrosis is a life-threatening complication in MPN with several therapeutic options including hematopoietic stem cell transplantation (HSCT) which remains the only curative treatment. Bone marrow biopsy with histological analysis allows myelofibrosis identification and staging. However, it is an invasive procedure that remains painful and provides potential haemorrhagic complications. Development of non-invasive biomarkers for myelofibrosis staging could help to better stratify this disease, better define patients' prognosis and lead to optimal cares. The main aim of this work is to develop a non-invasive blood score including several biomarkers for myelofibrosis staging in MPN using bone marrow biopsy as a gold standard.
A cross-sectional retrospective study of a sample of 20 women who completed single agent or multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured telephone interview. A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria below and are thus eligible for the study. These patients will be contacted via telephone by the principal investigator to inform them of the study and invite participation. A proposed sample size of 20 is sufficient to generate data to address the central questions and furthermore, this sample size is adequate because the intention is to gain insight into the experiences of patients' perceptions about their psychological experiences. Objectives: - Gaining insight into the emotional impact of GTN post treatment - Ascertaining if health professionals are providing adequate psychological support - Identifying sources of support that patients accessed post completion of treatment - Identifying potential areas of improvement in the follow up support for future patients Criteria for inclusion: - Treated with chemotherapy for a GTN diagnosis - Completed treatment between 6 weeks and 24 months - Are able to provide informed consent - Have no cognitive impairment as judged by the treating clinician Criteria for exclusion - Treatment received less than 6 weeks ago - Treatment received more than 24 months ago - Non-English speaking Outcome measures are not appropriate in this qualitative study. However outputs from this study include increasing knowledge and insight into: - patients' experiences of their psychological experiences post chemotherapy - patients' perspective of the support received after their treatment - potential areas of improvements in care
This study aims to compare the surgical outcomes of laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique versus the Warshaw technique. The primary focus is on the rates of unplanned splenectomy, occurrence of severe complications, as well as intraoperative and perioperative outcomes of both techniques.