PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03131934: Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant
Official title: Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant
Conditions: Post-transplant Lymphoproliferative Disease
Transplant-Related Hematologic Malignancy
Summary: This is an open label, non-randomised, multicentre Phase I to determine the safety of tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their expansion/persistence with control EBV CTL in solid organ transplant patients with post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).
Interventions:
description: Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the retroviral vector SFG-CNA12 conferring resistance to tacrolimus
name: Autologous EBV-CTL transduced with vector SFG-CNA12
type: Biological
description: Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the control retroviral vector SFG-CNA8
name: Autologous EBV-CTL transduced with control vector SFG-CNA8
type: Biological
description: Patients will undergo an unstimulated leucapheresis to isolate the required immune cells to produce the EBV-CTLs
name: Leucapheresis
type: Procedure
Study arms:
design_group_description: All patients will receive the autologous EBV CTL retrovirally transduced with with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8). For each patient two ATIMPs will be generated:<br/>* Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the retroviral vector SFG-CNA12<br/>* Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the control retroviral vector SFG-CNA8<br/>An equal dose (10x7/m2) of CNA12+ EBV CTL and CNA8+ EBV CTL will be administered intravenously on day 0.<br/>While awaiting ATIMP generation, patients may receive a single dose of Rituximab and other immunosuppressants (e.g. MMF) will be reduced, but tacrolimus will be maintained at therapeutic levels.
design_group_title: Autologous EBV-CTL transduced with SFG-CNA12/SFG-CNA8
design_group_type: Experimental
Sponsor: University College London
Collaborators: Genetix Biotherapeutics, Inc.
Drug name mappings:
name: Autologous EBV-specific cytotoxic T-cells(bluebird)
lang: EN
Clinical trial NCT01308242: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Official title: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Conditions: Chronic Kidney Disease
Summary: Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of progression of CKD and predict mortality in CKD. Although studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been reported. Our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will also be investigating associations of elevation in FGF 23 levels with commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and Hypertension.
Interventions:
description: Sevelamer 800 mg by mouth three times daily with meals for 3 months
name: Sevelamer Carbonate
other_name: Renvela
type: Drug
Study arms:
design_group_description: Patients enrolled will receive Renvela for a 3 month time frame.
design_group_title: Treatment
design_group_type: Experimental
Sponsor: Hershey Medical Center
Collaborators: Genzyme Corp.
Drug name mappings:
name: 碳酸司维拉姆
lang: CN
name: Sevelamer Carbonate
lang: EN
Clinical trial NCT07052760: Imaging of Solid Tumors Using DLL3 SPECT
Official title: Imaging of Solid Tumors Using DLL3 SPECT
Conditions: Solid Tumor Cancer
Castration Resistant Prostate Cancer
Castration Resistant Prostate Cancer (CRPC)
Neuroendocrine (NE) Tumors
Summary: This is a single arm, pilot trial that evaluates the ability of a novel imaging agent (111In-ABD147) to detect metastatic cancer in participants with solid tumors. 111In-ABD147 is a high affinity Delta-like ligand 3 (DLL3) antigen binding domain fused to an engineered humanized Fc to create an antibody (VHH-Fc) that is bio-conjugated with a DOTA linker-chelator to a 111In radiometal. DLL3 is expressed on a variety of tumors, particularly those with neuroendocrine features.
Interventions:
description: Given intravenously (IV) prior to imaging
name: 111In-ABD147
other_name: Radioimmunoconjugate
type: Drug
description: Undergo imaging
name: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
other_name: SPECT/CT
type: Procedure
Study arms:
design_group_description: Participants will receive a single administration of 185 megabecquerels (MBq) (5 millicurie (mCi)) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
design_group_title: Cohort 1: Castration resistant prostate cancer
design_group_type: Experimental
design_group_description: Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
design_group_title: Cohort 2: High grade neuroendocrine tumor
design_group_type: Experimental
design_group_description: Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
design_group_title: Cohort 3: Agnostic solid tumors
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: Abdera Therapeutics, Inc.
Drug name mappings:
name: ABD-147
lang: EN
Clinical trial NCT06639191: [177Lu]Lu-AKIR001 First-in-human Study
Official title: A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours
Conditions: Thyroid Gland Anaplastic Carcinoma
Poorly Differentiated Thyroid Carcinoma
Cancer Head and Neck
Cervix Carcinoma
Vulvar Cancer, Stage IV
Non-small Cell Lung Cancer Stage IV
Summary: The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of [177Lu]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is:
• What is the toxicity profile of the study drug [177Lu]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one [177Lu]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.
Interventions:
description: Patient cohorts of a minimum of three and a maximum of 12 evaluable participants will be opened according to the decision tree defined in the protocol and will be consecutively completed. When one cohort has been completed and fully evaluated, the next cohort will be opened after all participants in the previous cohort have received at least one dose of the IMP without dose-limiting toxicities during a follow-up period of at least six weeks.<br/>The [177Lu]Lu-AKIR001 protein mass dose and activity are predefined for each cohort, and could be adjusted according to the results of previous cohort(s) to ensure the safety of participants. The initial design of the trial encompasses five cohorts to escalate both [177Lu]Lu-AKIR001 pmd, from 50 mg to 100 mg, and activity, from 0.75 to 3.0 GBq.
name: [177Lu]Lu-AKIR001
type: Drug
Study arms:
design_group_description: In the successive cohorts, increasing doses of radioactivity (177-Lu) and CD44v6-targeted antibody (AKIR001) are given. A new dose cohort is opened only when toxicity in the previous dose cohort has deemed acceptable by the trial steering committee and the independent Data Safety Monitoring Board.
design_group_title: This is a single arm trial where patients are included in successive cohorts
design_group_type: Experimental
Sponsor: Karolinska University Hospital
Collaborators: Karolinska Institutet
University of Uppsala
Drug name mappings:
name: [177Lu]Lu-AKIR001
lang: EN
Clinical trial NCT04011293: A Clinical Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (CNCT19) in the Treatment of Cluster of Differentiation 19 (CD19) Positive Relapsed or Refractory B Cell Malignancies
Official title: A Clinical Study of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory B Cell Malignancies
Conditions: Relapsed or Refractory Hematological Malignancies
Summary: This is a single arm, open-label, single center study to determine the safety and efficacy of CNCT19 in adult patients with Relapsed or Refractory B cell Malignancies.
Interventions:
description: 0.5 to 4 x 10^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10^8 autologous CNCT19 transduced cells via intravenous infusion.
name: CNCT19
type: Biological
Study arms:
design_group_description: Single dose of CNCT19
design_group_title: A
design_group_type: Experimental
Sponsor: Shandong University
Collaborators: Juventas Cell Therapy Ltd.
Drug name mappings:
name: 纳基奥仑赛
lang: CN
name: Inaticabtagene Autoleucel
lang: EN
Clinical trial NCT04461457: Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Official title: Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
Conditions: Ovarian Cancer
Summary: In this alpha-radioimmunotherapy study groups of 3 patients with recurring epithelial ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one intra peritoneal infusion of 211 astatine (211At)-MX35 F(ab')2 . Patients will receive a single dose of MX35 F(ab')2 radiolabeled with increasing activity concentration of 211At in 1.0 - 2 L Extraneal® solution starting at an activity concentration of 50 megabecquerel per litre (MBq/L).
Interventions:
description: Alpha emitting radionuclide 211At conjugated to monoclonal antibody MX35 F(ab')2. Targeting the sodium phosphate transporter (NaPi2b).
name: 211-astatine MX35 F(ab')2
type: Combination Product
Study arms:
design_group_description: Four groups of 3 patients with recurring ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one IP dose of 211astatine-MX35 F(ab'2). Starting at 50 MBq/L. Dose escalation 100 Mbq/L, 200 MBq/L and finally 300 MBq/L.
design_group_title: Intraperitoneal Radioimmunotherapy boost
design_group_type: Experimental
Sponsor: Region Västra Götaland
Collaborators: Sahlgrenska Universitetssjukhuset
Vetenskapsrådet
Drug name mappings:
name: 211-astatine-MX35 F(ab')2(Memorial Sloan-Kettering Cancer Center)
lang: EN
Clinical trial NCT05516472: Fecal Microbiota Transplantation in Kidney Stone Patients
Official title: Fecal Microbiota Transplantation (FMT CAPSULE DE, FMPCapDE, MTP-CP101) in Kidney Stone Patients (FMT IND STUDY)
Conditions: Kidney Stones
Summary: The purpose of this study is to measure the impact of Microbial Transplant Therapy (MTT) on 24-hour urine parameters in recurrent hypercalciuric and hyperoxaluric kidney stone formers.
Interventions:
description: Participants will take microbial capsules, 2 capsules daily for 7 days
name: Microbial Transplant Therapy
other_name: fecal transplant
type: Drug
description: Participants will take placebo capsules
name: Placebo
type: Drug
Study arms:
design_group_description: Treatment group based on 24 hour urine analysis showing oxalate >40 mg/day.
design_group_title: Hyperoxaluric group
design_group_type: Experimental
design_group_description: Treatment group based on 24 hour urine analysis showing urinary calcium >225 mg/day.
design_group_title: Hypercalciuric Group
design_group_type: Experimental
design_group_description: Control group enrolling patients with hyperoxaluria
design_group_title: Control group Hyperoxaluria
design_group_type: Placebo Comparator
design_group_description: Control group enrolling patients with hypercalciuria
design_group_title: Control group Hypercalciuria
design_group_type: Placebo Comparator
Sponsor: Intermountain Health (Utah)
Collaborators: University of Minnesota
Drug name mappings:
name: Fecal Microbiota(Litholink)
lang: EN
Clinical trial NCT04167761: Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Official title: Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Conditions: Cardiovascular Diseases
Atherosclerosis
Type 2 Diabetes
Insulin Resistance
Summary: The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.
Interventions:
description: Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue
name: Ertugliflozin
other_name: SGLT2 inhibitor
type: Drug
Study arms:
design_group_description: Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues
design_group_title: Ertugliflozin (treated tissue)
design_group_type: Experimental
Sponsor: Stanford University
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 艾托格列净
lang: CN
name: Ertugliflozin pidolate
lang: EN
Clinical trial NCT07358234: Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.
Official title: Prospective Trial Comparing Swallowed Topical Budesonide With Subcutaneous Dupilumab on Esophageal Diameter and Fibrotic Change in Eosinophilic Esophagitis
Conditions: Eosinophilic Esophagitis (EoE)
Summary: The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.
Interventions:
description: 300 mg weekly injection
name: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
type: Drug
description: 2mg twice daily
name: budesonide oral suspension
other_name: Eohilia
type: Drug
Study arms:
design_group_description: 2mg twice daily
design_group_title: budesonide oral suspension (Eohilia)
design_group_type: Active Comparator
design_group_description: 300 mg weekly injection
design_group_title: dupilumab (Dupixent)
design_group_type: Active Comparator
Sponsor: Mayo Clinic
Collaborators: Vanderbilt University Medical Center
Drug name mappings:
name: 度普利尤单抗
lang: CN
name: Dupilumab
lang: EN
name: デュピルマブ（遺伝子組換え）
lang: JP
name: 布地奈德
lang: CN
name: Budesonide
lang: EN
name: ブデソニド
lang: JP
Clinical trial NCT07420530: Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion
Official title: Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion
Conditions: Exercise-Induced Vocal Cord Dysfunction
Paradoxical Vocal Fold Motion
Vocal Cord Dysfunction
Summary: The overall objectives of the proposed research are to:
1. Evaluate the diagnostic validity of a novel mechano-acoustic signatures of task-characteristic activity during symptomatic and asymptomatic breathing in Exercise-Induced Laryngeal Obstruction (EILO) patients with the use of a novel miniature, soft wearable skin-mounted device,
2. Identify the mechanism/s of paradoxical respiratory control in EILO by quantifying the relationship between pulmonary mechanics, partial pressure of carbon dioxide (PCO2) maintenance, and vocal fold aperture prior to and during symptomatic and asymptomatic exercise ventilation, and
3. Identify unique biophysiological factors contributing to EILO among exercisers with and without EILO. Findings will be highly novel and clinically significant for early identification and management of EILO.
For the study there are three separate visits:
1. Free running with the device on the neck
2. Exercise treadmill study
3. Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.
Interventions:
description: Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))
name: Carbon Dioxide
type: Drug
description: Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design
name: Breathing treatment
type: Behavioral
Study arms:
design_group_description: Participants will breathe room air
design_group_title: Control Arm
design_group_type: No Intervention
design_group_description: Participants will breathe Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen)).
design_group_title: Experimental Arm
design_group_type: Experimental
design_group_description: Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design
design_group_title: Breathing exercise
design_group_type: Other
Sponsor: Indiana University
Collaborators: National Jewish Health, Inc.
Purdue University
National Institute on Deafness & Other Communication Disorder
The Indiana University School of Medicine
Drug name mappings:
name: 二氧化碳
lang: CN
name: Carbon Dioxide
lang: EN
name: 二酸化炭素
lang: JP
Clinical trial NCT07239895: Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
Official title: Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans
Conditions: Pediatric Bronchiolitis Obliterans
Summary: Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing. Among children, the most common form of BO is post-infectious BO with a lack of treatment guidelines or standard therapy. In this study, an open, single-armed study is performed to preliminarily evaluate the safety and efficacy of airway basal stem cells on treatment of pediatric BO.
Interventions:
description: Airway Basal Stem Cells
name: Airway Basal Stem Cells
type: Biological
Study arms:
design_group_title: Airway Basal Stem Cells
design_group_type: Experimental
Sponsor: Regend Therapeutics Co. Ltd.
Collaborators: Shanghai Children's Hospital
Drug name mappings:
name: Airway Basal Stem Cells(Regend Therapeutics)
lang: EN
Clinical trial NCT06110208: Study to Evaluate the Safety and Preliminary Efficacy of CLL1 and CD38 Dual CAR-T in r/r AML
Official title: Clinical Study to Evaluate the Safety and Preliminary Efficacy of CLL1 and CD38 Dual CAR-T Injection in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
Conditions: Acute Myeloid Leukemia
Summary: This study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .
Interventions:
description: CLL1 and CD38 dual-target CAR-T injection
name: CLL1 and CD38 dual-target CAR-T injection
type: Drug
Study arms:
design_group_description: This study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population was patients with relapsed and refractory acute myeloid leukemia (r/r AML) .
design_group_title: AML subjects
design_group_type: Experimental
Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborators: Gracell Biotechnologies (Shanghai) Co., Ltd.
Drug name mappings:
name: CLL1 and CD38 dual-target CAR-T(Gracell Biotechnology Shanghai)
lang: EN
Clinical trial NCT06205342: Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Official title: STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Conditions: Chronic Pancreatitis
Chronic Pain
Summary: This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mechanisms of MSC action.
Interventions:
description: Autologous bone marrow derived MSCs
name: Mesenchymal Stem Cells
other_name: MSCs
type: Drug
description: Control
name: Other: Placebo
other_name: Controls
type: Other
Study arms:
design_group_description: MSC
design_group_title: Experimental Cohort
design_group_type: Experimental
design_group_description: Placebo
design_group_title: Validation Cohort
design_group_type: Placebo Comparator
Sponsor: The Medical University of South Carolina
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: Autologous Bone Marrow Derived Mesenchymal Stem Cells(Medical University of South Carolina)
lang: EN
Clinical trial NCT06045091: To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
Official title: A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Conditions: Multiple Myeloma
Plasma Cell Leukemia
Summary: This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.
Interventions:
description: Allogenic genetically modified anti-BCMA CAR transduced NK cells
name: Human BCMA targeted CAR-NK cells injection
other_name: BCMA CAR-NK
type: Drug
Study arms:
design_group_description: Two doses on Day 0 and Day 7. 1.5×10^8 CAR+NK cells/dose, 3.0×10^8 CAR+NK cells/dose or 6.0×10^8 CAR+NK cells/dose
design_group_title: Human BCMA Targeted CAR-NK Cells Injection
design_group_type: Experimental
Sponsor: Hrain Biotechnology Co., Ltd.
Collaborators: Shanghai Changzheng Hospital
Drug name mappings:
name: HR-012
lang: EN