PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05485753: A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)
Official title: An Open, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)
Conditions: Primary Central Nervous System Lymphoma
Secondary Central Nervous System Lymphoma
Summary: In this study, the safety and preliminary efficacy of GNC-038 in patients with r relapsed or refractory primary central nervous system lymphoma (PCNSL) and relapsed or refractory secondary central nervous system lymphoma (SCNSL) will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-038. The recommended dose for phase II (RP2D) clinical study will also be determined.
Interventions:
description: Administration by intravenous infusion
name: GNC-038
type: Drug
Study arms:
design_group_description: Participants receive GNC-038 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
design_group_title: Study treatment
design_group_type: Experimental
Sponsor: Sichuan Baili Pharmaceuticals Co.,Ltd
Collaborators: Baili Bio Chengdu Pharmaceutical Co. Ltd.
Systimmune, Inc.
Drug name mappings:
name: GNC-038
lang: EN
Clinical trial NCT00829647: A Study Using Two Oral Chemotherapy Agents for Chronic Lymphocytic Leukemia
Official title: A Phase I/II Study of Combination Dasatinib and Lenalidomide in Purine Analogue-Failed Chronic Lymphocytic Leukemia
Conditions: Chronic Lymphocytic Leukemia
Leukemia
Summary: Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of the blood. This study is experimental because neither drug has been approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia. There are few standard treatments when fludarabine is no longer effective in patients with CLL. Some patients have received additional combination therapy with fludarabine, Campath, bone marrow transplants or supportive care. Dasatinib and lenalidomide have been effective in high-risk CLL patients in other pilot mono therapy studies. The combination of dasatinib and lenalidomide has not been studied in humans before and this study is designed to test whether this combination is safe to use.
Interventions:
description: dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po
name: dasatinib and lenalidomide
other_name: spyrcel and revlimid
type: Drug
Study arms:
design_group_description: dasatinib 70 mg po daily plus lenalidomide 2.5 md po daily
design_group_title: combination dasatinib plus lenalidomide
design_group_type: Experimental
Sponsor: Scripps Health
Collaborators: Bristol Myers Squibb Co.
Celgene Corp.
Drug name mappings:
name: 来那度胺
lang: CN
name: Lenalidomide
lang: EN
name: レナリドミド水和物
lang: JP
name: 达沙替尼
lang: CN
name: Dasatinib
lang: EN
name: ダサチニブ水和物
lang: JP
Clinical trial NCT03858491: Pharmacokinetic Boosting of Osimertinib
Official title: Pharmacokinetic Boosting of Osimertinib in Patients With Non-small Cell Lung Cancer.
Conditions: Non Small Cell Lung Cancer
Summary: The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.
Interventions:
description: Cobicistat will be added to the treatment with osimertinib. The initial dose will be 150 mg cobicistat, which equals the dose used in the treatment of HIV-infected patients. If this dose is well tolerated and the increase in exposure of osimertinib is not sufficient, the dose of cobicistat will gradually be escalated to 600 mg per day (150 mg cobicistat, four times per day).
name: Cobicistat
other_name: Tybost
type: Drug
Study arms:
design_group_description: Cobicistat will serve as experimental drugs, and will be added to the regular treatment with osimertinib. Combination-treatment will be started at 150 milligram cobicistat, and can be increased to a maximum daily dose of 600 milligram cobicistat (four times 150 milligram).
design_group_title: Cobicistat
design_group_type: Experimental
Sponsor: Academisch Ziekenhuis Maastricht
Collaborators: Netherlands Cancer Insitute
ZonMw
Drug name mappings:
name: 考比司他
lang: CN
name: Cobicistat
lang: EN
Clinical trial NCT00815646: Prevention and Treatment of Immersion Pulmonary Edema
Official title: Effects of the Dive Reflex on Pulmonary Arterial and Pulmonary Artery Wedge Pressures in Subjects Who Have Experienced Immersion Pulmonary Edema
Conditions: Immersion Pulmonary Edema (IPE)
Swimming Induced Pulmonary Edema (SIPE)
Summary: Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving or swimming, particularly in cold water. Some individuals appear to be predisposed to developing IPE. DNA samples will be collected and stored, in order to compare the genetic profiles of individuals who have experienced IPE with those who have not. In a few individuals who have experienced IPE, we plan to measure the effects of cold water immersion on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will be compared with similar measurements already obtained from normal individuals.
Interventions:
description: After measurement of the effect of cold water on cardiac output and pulmonary artery and wedge pressures, a single dose of sildenafil (50 mg) will be given orally, followed by similar hemodynamic measurements.
name: Sildenafil
other_name: Viagra
type: Drug
Study arms:
design_group_description: Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.
design_group_title: Sildenafil
design_group_type: Experimental
Sponsor: Duke University
Collaborators: Divers Alert Network (DAN)
Drug name mappings:
name: 枸橼酸西地那非
lang: CN
name: Sildenaifl Citrate
lang: EN
name: シルデナフィルクエン酸塩
lang: JP
Clinical trial NCT04020419: Natural Berry Extract Treatment of Hemangiomas
Official title: Natural Berry Extract Treatment of Hemangiomas
Conditions: Hemangioma
Summary: This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. Subjects will be followed to age 18 months. A total of 44 subjects will be PediaBerry group and 22 subjects in the placebo control group.
Interventions:
description: PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration
name: PediaBerry
other_name: placebo
type: Drug
Study arms:
design_group_description: PediaBerry™ is a proprietary blend powdered berry extracts
design_group_title: Pediaberry group
design_group_type: Experimental
design_group_description: Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ).
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Indiana University
Collaborators: National Institute of General Medical Sciences
National Institutes of Health
Drug name mappings:
name: 浆果提取物
lang: CN
name: Berry extract
lang: EN
Clinical trial NCT03815071: A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
Official title: Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
Conditions: Parkinson Disease
Summary: This is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease
Interventions:
description: Total dose of ips-nsc cells will be administered at day0.
name: Ips-nsc cells
type: Drug
Study arms:
design_group_title: ips-nsc treatment group
design_group_type: Experimental
Sponsor: Beijing Allife Medicine Technology Co., Ltd.
Collaborators: Henan Provincial Peoples Hospital
Beijing Hospital of the Ministry of Health
Drug name mappings:
name: iPS-NSC cells(Allife Medical Science and Technology)
lang: EN
Clinical trial NCT05126927: A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors
Official title: A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.
Conditions: Solid Tumor
Summary: Primary objective To investigate the safety and tolerability profile of 68Ga- NODAGA-SNA006 in patients with solid tumors; To investigate the radiation absorbed dose characteristics of 68Ga-NODAGA-SNA006 in patients with solid tumors; To investigate the distribution profile of 68Ga-NODAGA-SNA006 in patients with solid tumors. Secondary objectives To investigate the optimal administration dose and radiation safety profile of 68Ga-NODAGA-SNA006; To investigate the PET imaging characteristics and high-quality imaging time window of 68Ga-NODAGA-SNA006 in patients with solid tumors; To explore the correlation between PET imaging characteristics of 68Ga-NODAGA-SNA006 binding to CD8 and histological CD8 expression characteristics; To explore peripheral blood T lymphocyte differentiation (CD8, CD4, CD3, etc.) in patients with solid tumors.
Interventions:
description: A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors
name: 68Ga-NODAGA-SNA006
type: Biological
Study arms:
design_group_description: A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors
design_group_title: 68Ga-NODAGA-SNA006
design_group_type: Experimental
Sponsor: Suzhou SmartNuclide Biopharmaceutical Co., Ltd.
Collaborators: The First Affiliated Hospital of Soochow University
Drug name mappings:
name: 68Ga-NODAGA-SNA006
lang: EN
Clinical trial NCT00962845: Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
Official title: A Phase 0 Trial of Hydroxychloroquine, an Inhibitor of Autophagy, in Patients With Stage III or IV Resectable Melanoma
Conditions: Melanoma (Skin)
Summary: RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients with melanoma receiving hydroxychloroquine may help doctors understand the effect of hydroxychloroquine on biomarkers.
PURPOSE: This early phase I trial is studying hydroxychloroquine in patients with stage III or stage IV melanoma that can be removed by surgery.
Interventions:
description: 200 mg twice daily in the first ten patients. If the first ten patients tolerate this dosage schedule (200 mg bid) without significant side effects (Grade 3 or greater gastrointestinal upset, skin toxicity, myopathy or any visual disturbances whatsoever), the second ten patients will be enrolled at a dose of 400 mg bid
name: hydroxychloroquine
type: Drug
Study arms:
design_group_description: Patients must have tumor accessible for pre-treatment biopsy (see 5.1.2). Patients will be enrolled on the trial, undergo biopsy of their tumors if no banked tumor is available, and then begin an oral dose of HCQ at the dose of 200 mg twice daily. At the end of two weeks the patients will undergo resection of their tumors. HCQ will be given to the patients up to the day of the operation but not resumed postoperatively.
design_group_title: Hydroxychloroquine
design_group_type: Experimental
Sponsor: Rutgers State University of New Jersey
Collaborators: National Cancer Institute
Rutgers Cancer Institute of New Jersey
Drug name mappings:
name: 硫酸羟氯喹
lang: CN
name: Hydroxychloroquine Sulfate
lang: EN
name: ドロキシクロロキン硫酸塩
lang: JP
Clinical trial NCT06613490: An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Official title: An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Conditions: Antisynthetase Syndrome
Rheumatoid Arthritis
Summary: A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.
Interventions:
description: This study is a single-arm, open-label and single-center exploratory clinical study to evaluate the safety and effectiveness of anti CD19 CAR NK cells in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA). All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by Anti-CD19 CAR NK cells infusion.
name: anti CD19 CAR NK cells
type: Biological
Study arms:
design_group_title: anti CD19 CAR NK cells
design_group_type: Experimental
Sponsor: Third Affiliated Hospital of Nanjing Medical University
Collaborators: Rui Therapeutics Co., Ltd
Drug name mappings:
name: KN-5501
lang: EN
Clinical trial NCT01239875: Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma
Official title: LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With B-Cell Non-Hodgkin's Lymphoma"
Conditions: Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Adult Diffuse Mixed Cell Lymphoma
Adult Diffuse Small Cleaved Cell Lymphoma
Adult Grade III Lymphomatoid Granulomatosis
Adult Immunoblastic Large Cell Lymphoma
Adult Lymphoblastic Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia With Nodal Disease
Summary: RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's lymphoma.
Interventions:
description: Given intratumorally
name: dendritic cell vaccine therapy
type: Biological
description: Undergo cryoablation
name: cryotherapy
type: Procedure
description: Given intramuscularly
name: pneumococcal polyvalent vaccine
other_name: Pneumovax 23
Pnu-Imune 23
type: Biological
description: Correlative studies
name: laboratory biomarker analysis
type: Other
description: Correlative studies
name: immunoenzyme technique
other_name: immunoenzyme techniques
type: Other
description: Correlative studies
name: immunohistochemistry staining method
other_name: immunohistochemistry
type: Other
description: Given intradermally
name: autologous dendritic cell-tumor fusion vaccine
type: Biological
Study arms:
design_group_description: Patients receive pneumococcal polyvalent vaccine intramuscularly in weeks -4, 2, and 10. Patients undergo cryoablation followed by dendritic cell vaccine (CA-DC) intratumorally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.
design_group_title: Arm A
design_group_type: Experimental
design_group_description: Patients receive pneumococcal polyvalent vaccine as in arm A. Patients also receive autologous dendritic cell-tumor fusion vaccine (TL-DC) intradermally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.
design_group_title: Arm B
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute
Drug name mappings:
name: Autologous dendritic cell-tumor fusion vaccine(Mayo Clinic)
lang: EN
name: Autologous Dendritic Cells(Mayo Clinic)
lang: EN
Clinical trial NCT06629428: Effects of Ublituximab on Motor Functions in Multiple Sclerosis
Official title: Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People With Relapsing Multiple Sclerosis
Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
Summary: The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.
Interventions:
description: The participants will receive 48 weeks of treatment with ublituximab.
name: Ublituximab
type: Drug
Study arms:
design_group_description: This arm will receive a 48-week ublituximab treatment.
design_group_title: Ublituximab
design_group_type: Experimental
Sponsor: Georgia State University
Collaborators: Atlanta Neuroscience Institute
Drug name mappings:
name: Ublituximab
lang: EN
Clinical trial NCT05566600: Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure
Official title: Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
Conditions: Ischemic Heart Failure
Chronic Heart Failure
Summary: This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery.
After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
Interventions:
description: 10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
name: Human (allogeneic) iPS-cell-derived cardiomyocyte
type: Biological
Study arms:
design_group_description: 100 million iPSC-CMs administration
design_group_title: Dose level 1
design_group_type: Experimental
design_group_description: 200 million iPSC-CMs administration
design_group_title: Dose level 2
design_group_type: Experimental
design_group_description: 400 million iPSC-CMs administration
design_group_title: Dose level 3
design_group_type: Experimental
design_group_description: Participants will received CABG surgery only
design_group_title: Control
design_group_type: No Intervention
Sponsor: Help Therapeutics Ltd.
Collaborators: Central South University
Drug name mappings:
name: 人iPSC来源心肌细胞（艾尔普）
lang: CN
name: iPSC derived cardiac muscle cell (Help Therapeutics)
lang: EN
Clinical trial NCT01174056: Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
Official title: Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
Conditions: Lung Inflammation
Summary: The purpose of this research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves inflammation that is not specific to one area of the lung and is caused by any one of several conditions: infection, trauma, breathing toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death.
Interventions:
description: 600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
name: Zileuton
other_name: Zyflo
type: Drug
description: Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
name: Pioglitazone placebo
type: Drug
description: Placebo tablets provided by manufacturer of Zyflo CR (Cornerstone Therapeutics), 2 tablets po bid x 5 days prior to endotoxin instillation until 24 hours after endotoxin.
name: Zileuton placebo
type: Drug
description: PPAR-gamma agonist
name: Pioglitazone
other_name: Actos
type: Drug
Study arms:
design_group_description: Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
design_group_title: Pioglitazone+zileuton placebo
design_group_type: Experimental
design_group_description: Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
design_group_title: Zileuton+pioglitazone placebo
design_group_type: Experimental
design_group_description: Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days
design_group_title: Pioglitazone placebo+zileuton placebo
design_group_type: Sham Comparator
Sponsor: Washington University School of Medicine
Collaborators: Doris Duke Foundation
Drug name mappings:
name: 盐酸吡格列酮
lang: CN
name: Pioglitazone Hydrochloride
lang: EN
name: ピオグリタゾン塩酸塩
lang: JP
name: 齐留通
lang: CN
name: Zileuton
lang: EN
Clinical trial NCT07338604: Clinical Study of UTAA07 Injection in the Treatment of Hematologic and Lymphatic Systemic Malignancies
Official title: Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies
Conditions: Hematolymphoid Malignancies
Summary: This is a single-arm, open-label study designed to evaluate the safety, tolerability and cellular pharmacokinetic profiles of UTAA07 Injection. It also aims to preliminarily assess the efficacy of the investigational drug in subjects with relapsed/refractory hematolymphoid malignancies, so as to identify the optimal dose for subsequent formal clinical trials.
Interventions:
description: CAR-T cell infusion
name: CAR-T cell infusion
type: Drug
description: UTAA07 Injection is a chimeric antigen receptor (CAR)-engineered γδ T-cell product that targets the CD7 antigen expressed on the surface of tumor cells.
name: UTAA07 injection
type: Drug
Study arms:
design_group_title: UTAA07 injection
design_group_type: Experimental
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators: The First Affiliated Hospital of Soochow University
Drug name mappings:
name: UTAA-07
lang: EN