PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05098171: A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)
Official title: A Clinical Study on Signal Switch Receptor Modified Tumor Infiltrating Lymphocytes Injection (GC201 TIL) in Patients With Gynecologic Tumors
Conditions: Advanced Gynecologic Tumors
Signal Switch Receptor Modified TIL
Treatment Side Effects
Effects of Immunotherapy
Summary: This study is to investigate the safety and efficacy of signal switch receptor modified TIL (GC201 TIL) in patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified(TGF-β receptor or PD-1 gene modified TILs which could transfer the suppression signal surrounding the microenvironment of tumor bed into persistent T cell activation signal) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Interventions:
description: Adoptive transfer of 2x10^8-1x10^10 autologous signal switch receptor modified TILs to patients i.v. in 30-120 minutes.
name: Signal Switch Receptor Modified TIL
type: Biological
Study arms:
design_group_description: 2x10^8-1x10^10 in vitro expanded autologous PD-1 or TGF-β signal switch receptor modified TIL (GC201 TIL) will be infused i.v. to patients with advanced gynecologic tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
design_group_title: Signal Switch Receptor Modified TIL
design_group_type: Experimental
Sponsor: Shanghai Gencells Therapeutics Co., Ltd.
Collaborators: Shanghai No. 10 People's Hospital
Drug name mappings:
name: GC201 TIL(Shanghai Gencells Therapeutics)
lang: EN
Clinical trial NCT06653556: A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
Official title: An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)
Conditions: Systemic Lupus Erythematosus (SLE)
Summary: This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
Interventions:
description: Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.
name: LCAR-AIO T cells
type: Biological
Study arms:
design_group_description: Experimental: Chimeric antigen receptor T cells (LCAR-AIO)<br/>Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level
design_group_title: LCAR-AIO T Cells
design_group_type: Experimental
Sponsor: Wuhan Xiehe Hospital Tower
Collaborators: Nanjing Legend Biotech Co., Ltd.
Drug name mappings:
name: LCAR-AIO(Legend Biotech)
lang: EN
Clinical trial NCT06414408: Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Official title: Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Conditions: Sexually Transmitted Diseases, Bacterial
Summary: Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis
Interventions:
description: 200mg Dose
name: Doxycycline Pill
type: Drug
Study arms:
design_group_description: Participants will be randomized to take once daily doxycycline 200mg for six weeks.
design_group_title: Daily Dosing
design_group_type: Active Comparator
design_group_description: Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks.
design_group_title: Three-times Weekly Dosing
design_group_type: Active Comparator
design_group_description: Participants will be randomized to take one doxycycline 200mg dose once week.
design_group_title: Weekly Dosing
design_group_type: Active Comparator
design_group_description: Participants will be randomized to take one doxycycline 200mg dose every other week.
design_group_title: Every Other Week Dosing
design_group_type: Active Comparator
Sponsor: The University of California, San Francisco
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 盐酸多西环素
lang: CN
name: Doxycycline Hyclate
lang: EN
name: ドキシサイクリン塩酸塩水和物
lang: JP
Clinical trial NCT03001349: 68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors
Official title: An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC
Conditions: Meningioma
Metastatic Well Differentiated Neuroendocrine Neoplasm
Multiple Endocrine Neoplasia Type 1
Neuroendocrine Neoplasm
Somatostatin Positive Neoplastic Cells Present
Von Hippel-Lindau Syndrome
Summary: This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.
Interventions:
description: Undergo PET/CT
name: Computed Tomography
other_name: CAT
CAT Scan
CT
CT SCAN
Computerized Axial Tomography
computerized tomography
tomography
type: Procedure
description: Given IV
name: Gallium Ga 68-Edotreotide
other_name: 68Ga-DOTA-TOC
68Ga-DOTA-d-Phe1-Tyr3-octreotide
EDOTREOTIDE GALLIUM GA-68
Ga-68 DOTA0-Tyr3-octreotide
Ga-68 DOTATOC
Ga-68-DOTA-TOC
Ga-68-DOTA-Tyr(3)-octreotide
Gallium Ga 68-DOTATOC
type: Drug
description: Undergo PET/CT
name: Positron Emission Tomography
other_name: Medical Imaging, Positron Emission Tomography
PET
PET Scan
Positron Emission Tomography Scan
Positron-Emission Tomography
proton magnetic resonance spectroscopic imaging
type: Procedure
Study arms:
design_group_description: Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.
design_group_title: Diagnostic (gallium Ga 68-edotreotide, PET/CT)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 镓[68Ga]伊索曲肽
lang: CN
name: 68Ga-Edotreotide
lang: EN
Clinical trial NCT06092047: UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
Official title: Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.
Conditions: CD19-positive Relapsed or Refractory B-cell Malignancies
Summary: This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
Interventions:
description: Intravenous injection, dosage:1-10×10^8 CAR+ γδT cells, Cell concentration: 2×10^7 cells/mL.
name: UTAA09 cells for infusion
type: Biological
description: 30 mg/m^2/day×4 days
name: Fludarabine
type: Drug
description: 1000 mg/m^2/day×3 days
name: Cyclophosphamide
type: Drug
Study arms:
design_group_description: Off-the-shelf γδT cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day-7<br/>Day-2.
design_group_title: UTAA09 cells for infusion
design_group_type: Experimental
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators: Anhui Provincial Hospital
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: UTAA09/17
lang: EN
Clinical trial NCT04853082: Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
Official title: Clinical Trial of Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
Conditions: Fatty Liver
Summary: The prevention and treatment of metabolic-related fatty liver disease (MAFLD) involves many fields in preventive medicine and clinical medicine. So far, western medicine has not yet completed the elucidation of the mechanism of this type of disease, and there is a lack of effective therapeutic drugs.The purpose of this study was to evaluate the effectiveness and safety of limonene capsules (marketed product in China) in the treatment of metabolic-related fatty liver disease and related lipid-lowering mechanisms.
Interventions:
description: All the recruiters will be given treatment under the guidance of basic diet. Basic dietary guidelines include high-quality protein and fresh green leafy vegetables. It need to controlled sugar, various sweets and high-calorie foods, frying and other foods with high oil content and foods with high cholesterol content. Limonene capsules group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo control group and limonene capsule administration group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the treatment group and the placebo control group at a ratio of 1:1. The drug was administered for 12 weeks, 3 times a day, 5 capsules each time.
name: Limonene capsule
other_name: DAN LENING capsule
type: Drug
description: Limonene capsules(Placebo)
name: Limonene capsules(Placebo)
type: Drug
Study arms:
design_group_description: Limonene capsules(marketed product in China) donate by pharmaceutical company
design_group_title: Limonene capsules(marketed product in China)
design_group_type: Active Comparator
design_group_description: Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules
design_group_title: Limonene capsules(Placebo)
design_group_type: Placebo Comparator
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Shanghai Shen Kang Hospital Development Center
Shanghai Jiao Tong University
Longhua Hospital Shanghai University of TCM
Drug name mappings:
name: 柠檬烯
lang: CN
name: Limonene
lang: EN
Clinical trial NCT02113657: T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
Official title: A Feasibility Study To Determine T-cell Responses To Neoantigens Following Treatment With Ipilimumab In Men With Metastatic Castration-Resistant Prostate Carcinoma
Conditions: Prostate Cancer
Summary: The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied.
This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma. Its use to treat prostate cancer is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Interventions:
description: 3 mg/kg by vein once every 3 weeks for a total of 4 doses.
name: Ipilimumab
other_name: BMS-734016
MDX010
Yervoy
type: Drug
Study arms:
design_group_description: Ipilimumab administered by vein at a dose of 3 mg/kg once every 3 weeks for a total of 4 doses.
design_group_title: Ipilimumab
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Bristol Myers Squibb Co.
Stand Up To Cancer
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
Clinical trial NCT07213882: A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)
Official title: A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)
Conditions: Cutaneous T Cell Lymphoma (CTCL)
Mycosis Fungoides
Sezary Syndrome
Summary: Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes. SS is defined as erythroderma (erythema of the entire skin surface), and circulating tumor blood cells. The circulating tumor T cells express CD4 and may lose expression of CD7 and CD26, while exhibiting in most cases aberrant expression of CD158k (KIR3DL2), which is a surface marker of Sézary cells. CCR8 is a surface marker of tumor-infiltrating regulatory T cells. It has recently be observed that CCR8 was expressed by tumor cells in CTCL and other peripheral T-cell lymphomas. CCR8 is expressed by skin resident-memory T cells which are believed to be the tumor cell-of-origin in mycosis fungoides. Domain Therapeutics (DT) showed the in vitro efficacy of their proprietary anti-CCR8 mAb DT7012 in the depletion of CTCL cells. Therapeutic depletion of CCR8-expressing cells by DT-7012 could eliminate tumor cells and activate the anti-tumor immunity in CTCL. We hypothesize that treatment with DT-7012 is effective in the treatment of relapsed or refractory (R/R) CTCL as advanced MF and SS.
Interventions:
description: This study use the Bayesian one-stage time-to-event continual reassessment method (TITE-CRM) design for dose finding phase I clinical trials, using an empirical dose-toxicity model with linear weights. A maximum total of 30 patients with CTCL, given 4 candidate dose levels (0.3; 1.0; 3.0; 10.0 mg/kg) will be dose-assigned starting from 1mg/kg dose level, in cohorts of 1 patient and including safety rules notably to ensure staggered accrual.
name: DT-7012
type: Drug
Study arms:
design_group_title: single agent DT-7012
design_group_type: Experimental
Sponsor: Assistance Publique des Hôpitaux de Paris SA
Collaborators: Kainova Therapeutics, Inc.
Drug name mappings:
name: DT-7012
lang: EN
Clinical trial NCT02886559: Chidamide Plus DCAG for Relapsed/Refractory AML
Conditions: AML
Relapse
Summary: Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The investigators designed a new regimen, including chidamide, decitabine, aclarubincin, cytarabine and G-CSF, to treat rrAML.
Interventions:
description: chidamide, decitabine, aclarubicin, cytarabine and G-CSF
name: Chidamide plus DCAG regimen
other_name: DCCAG regimen
type: Drug
Study arms:
design_group_description: Chidamide 30mg twice for one week decitabine 20mg/m^2 for 5 days
design_group_title: DCCAG
design_group_type: Experimental
Sponsor: Chinese People's Liberation Army General Hospital
Collaborators: Navy General Hospital
Drug name mappings:
name: 地西他滨
lang: CN
name: Decitabine
lang: EN
name: 西达本胺
lang: CN
name: Chidamide
lang: EN
name: ツシジノスタット
lang: JP
name: 盐酸阿柔比星
lang: CN
name: Aclarubicin Hydrochloride
lang: EN
name: アクラルビシン塩酸塩
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
Clinical trial NCT03294083: A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
Official title: A Phase 1b/2a Dose-escalation and Safety/Efficacy Evaluation Study of Pexa-Vec (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) in Combination With Cemiplimab (REGN2810; Anti-PD-1) in Patients With Metastatic or Unresectable Renal Cell Carcinoma (RCC)
Conditions: Renal Cell Carcinoma
Summary: This is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with Cemiplimab will be determined, followed by an expansion stage. During the expansion patients will receive Cemiplimab alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.
Interventions:
description: Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
name: Pexastimogene Devacirepvec (Pexa-Vec)
other_name: JX-594
type: Biological
description: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
name: Cemiplimab
type: Biological
Study arms:
design_group_description: Pexa-Vec will be administered via IV infusion at a dose of 3 x 10^8 pfu once per week for 4 treatments. Based on the occurrence of dose-limiting toxicities, patients may subsequently be enrolled to receive Pexa-Vec on the same schedule at a dose of 1 x 10^9 pfu.<br/>Cemiplimab will be administered via IV infusion every 3 weeks.
design_group_title: Part 1, Dose escalation
design_group_type: Experimental
design_group_description: Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments.<br/>Cemiplimab will be administered via IV infusion every 3 weeks.
design_group_title: Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab
design_group_type: Experimental
design_group_description: Cemiplimab will be administered via IV infusion every 3 weeks.<br/>At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks.
design_group_title: Part 2-Arm B, Cemiplimab
design_group_type: Experimental
design_group_description: Pexa-Vec will be administered via IV infusion once per week for 4 treatments.<br/>Cemiplimab will be administered via IV infusion every 3 weeks.
design_group_title: Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab
design_group_type: Experimental
design_group_description: Pexa-Vec will be administered via IV infusion once per week for 4 treatments.<br/>Cemiplimab will be administered via IV infusion every 3 weeks.
design_group_title: Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab
design_group_type: Experimental
Sponsor: SillaJen, Inc.
Collaborators: Regeneron Pharmaceuticals, Inc.
Drug name mappings:
name: 塞普利单抗
lang: CN
name: Cemiplimab-RWLC
lang: EN
name: セミプリマブ（遺伝子組換え）
lang: JP
name: Pexastimogene devacirepvec
lang: EN
Clinical trial NCT02180711: Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Official title: An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Conditions: Non Hodgkin Lymphoma
Summary: Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.
Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.
Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL
Interventions:
name: acalabrutinib
other_name: ACP-196
type: Drug
name: rituximab (IV)
type: Drug
name: Lenalidomide
type: Drug
Study arms:
design_group_description: acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
design_group_title: Part 1: acalabrutinib Regimen 1
design_group_type: Experimental
design_group_description: acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
design_group_title: Part 1: acalabrutinib Regimen 2
design_group_type: Experimental
design_group_description: acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
design_group_title: Part 2: acalabrutinib Regimen 1
design_group_type: Experimental
design_group_description: acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
design_group_title: Part 2: acalabrutinib Regimen 2
design_group_type: Experimental
design_group_description: acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
design_group_title: Part 3: acalabrutinib Regimen 1
design_group_type: Experimental
Sponsor: Acerta Pharma BV
Collaborators: AstraZeneca PLC
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: 阿可替尼
lang: CN
name: Acalabrutinib
lang: EN
name: アカラブルチニブ
lang: JP
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00538616: Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
Official title: A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
Conditions: Brain Injury
Intracranial Pressure
Summary: The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
Interventions:
description: in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
name: Dexmedetomidine
other_name: Precedex
type: Drug
description: in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
name: Propofol
other_name: Diprivan
type: Drug
Study arms:
design_group_description: Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
design_group_title: Precedex-Propofol
design_group_type: Active Comparator
design_group_description: Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
design_group_title: Propofol- Precedex
design_group_type: Active Comparator
Sponsor: Duke University
Collaborators: Hospira, Inc.
Drug name mappings:
name: 盐酸右美托咪定
lang: CN
name: Dexmedetomidine Hydrochloride
lang: EN
name: デクスメデトミジン塩酸塩
lang: JP
name: 丙泊酚
lang: CN
name: Propofol
lang: EN
name: プロポフォール
lang: JP