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Anti-Topoisomerase I Antibody

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141. Phase I study of the anti-CD22 antibody-drug conjugate pinatuzumab vedotin with/without rituximab in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. (PubMed)

Phase I study of the anti-CD22 antibody-drug conjugate pinatuzumab vedotin with/without rituximab in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. Purpose: Pinatuzumab vedotin is an antibody-drug conjugate with the potent antimicrotubule agent monomethyl auristatin E (MMAE) conjugated to an anti-CD22 antibody via a protease-cleavable linker. This phase I study determined its recommended phase II dose (RP2D) and evaluated its safety, tolerability, and antitumor activity alone (...) neutropenia >7 days in 1 of 3 patients and grade 4 neutropenia <7 days in 2 of 3 patients treated at 3.2 mg/kg (maximum assessed dose). No DLTs occurred at 2.4 mg/kg. At the RP2D, neutropenia was the most common grade ≥3 adverse event. Peripheral neuropathy-related grade ≥2 adverse events most frequently resulted in treatment discontinuation. Rituximab cotreatment did not impact safety, tolerability, or pharmacokinetics of pinatuzumab vedotin. Unconjugated MMAE exposure was much lower than antibody

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2016 Clinical Cancer Research

142. Pharmacokinetics, Pharmacodynamics, and Safety of MEDI4212, an Anti-IgE Monoclonal Antibody, in Subjects with Atopy: A Phase I Study. (PubMed)

Pharmacokinetics, Pharmacodynamics, and Safety of MEDI4212, an Anti-IgE Monoclonal Antibody, in Subjects with Atopy: A Phase I Study. The anti-IgE therapy omalizumab is currently licensed for the treatment of moderate to severe allergic asthma and chronic idiopathic urticaria. Owing to limitations in the use of omalizumab, a need exists for optimized anti-IgE therapies to broaden clinical indications and patient populations, and to improve dosing schedules. The objective of this phase I (...) , randomized, placebo/omalizumab-controlled, first-in-human, dose-escalation study was to evaluate the pharmacokinetics, pharmacodynamics, and safety of the high-affinity, anti-IgE therapy MEDI4212 in non-Japanese and Japanese subjects with atopy and/or diagnostic IgE ≥ 30 IU/mL.Subjects with atopy and/or baseline IgE ≥ 30 IU/mL were randomized to a single dose of subcutaneous (5, 15, 60, 150, or 300 mg) or intravenous (300 mg) MEDI4212, subcutaneous omalizumab, or placebo. Following administration

2016 Advances in therapy

143. Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study. (PubMed)

Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study. Systemic sclerosis (SSc) is a clinically heterogeneous, life-threatening disease characterized by fibrosis, microvasculopathy, and autoimmunity. Extensive nonclinical and clinical data implicate B cells in the pathogenesis of SSc. MEDI-551 is an investigational humanized monoclonal antibody that targets the B cell (...) surface antigen CD19 and mediates antibody-dependent, cell-mediated cytotoxicity of B cells. This clinical study evaluated the safety and tolerability, pharmacokinetics, and pharmacodynamics of MEDI-551 in subjects with SSc.This phase I multicenter, randomized, double-blind, placebo-controlled, single escalating dose study enrolled adult subjects with either limited or diffuse cutaneous SSc. A single intravenous dose of MEDI-551 was administered, and safety and tolerability were evaluated. MEDI-551

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2016 Arthritis research & therapy

144. Role of anti-domain 1-β<sub>2</sub> glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome. (PubMed)

Role of anti-domain 1-β2 glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome. Essentials Antibodies to domain 1 of β2 glycoprotein I (aD1) are a subset of antiphospholipid antibodies. We evaluated the added diagnostic value of an automated aD1 assay in antiphospholipid syndrome. AD1 IgG correctly classifies patients at risk for thrombosis. Agreement between aD1 and aβ2GPI IgG is high, limiting the added value of aD1 in our setting. Click (...) to hear Professor de Groot's perspective on new mechanistic understanding in antiphospholipid syndromeBackground Laboratory diagnosis of antiphospholipid syndrome (APS) includes lupus anticoagulant (LAC), anticardiolipin (aCL) or anti-β2 glycoprotein I (aβ2 GPI) antibodies. Antibodies targeting domain 1 of β2 GPI (aD1) constitute a pathogenic subset of autoantibodies. Objectives In this cohort study, we determined the clinical performance characteristics, additional diagnostic value

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2016 Journal of Thrombosis and Haemostasis

145. Phase I study of the investigational anti-guanylyl cyclase antibody-drug conjugate TAK-264 (MLN0264) in adult patients with advanced gastrointestinal malignancies. (PubMed)

Phase I study of the investigational anti-guanylyl cyclase antibody-drug conjugate TAK-264 (MLN0264) in adult patients with advanced gastrointestinal malignancies. To assess the safety, tolerability, and preliminary antitumor activity of the investigational anti-guanylyl cyclase C (GCC) antibody-drug conjugate TAK-264 (formerly MLN0264) in adult patients with advanced gastrointestinal malignancies.Adult patients with GCC-expressing gastrointestinal malignancies (H-score ≥ 10) were eligible

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2016 Clinical Cancer Research

146. Phase I study of chimeric anti-CD20 monoclonal antibody in Chinese patients with CD20-positive non-Hodgkin's lymphoma (PubMed)

Phase I study of chimeric anti-CD20 monoclonal antibody in Chinese patients with CD20-positive non-Hodgkin's lymphoma This study was designed to determine the safety, pharmacokinetics and biologic effects of a human-mouse chimeric anti-CD20 monoclonal antibody (SCT400) in Chinese patients with CD20-positive B-cell non-Hodgkin's lymphoma (CD20(+) B-cell NHL). SCT400 has an identical amino acid sequence as rituximab, with the exception of one amino acid in the CH1 domain of the heavy chain, which (...) reaction was mild. A rapid, profound and durable depletion of circulating B cells was observed in all dose groups without significant effects on T cell count, natural killer (NK) cell count or immunoglobulin levels. No patient developed anti-SCT400 antibodies during the course of the study. SCT400 serum half-life (T1/2), maximum concentration (Cmax) and area under the curve (AUC) generally increased between the first and fourth infusions (P<0.05). At the 375 mg/m(2) dose, the T1/2 was 122.5±46.7 h vs

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2016 Chinese Journal of Cancer Research

147. Phase I clinical study of RG7356, an anti-CD44 humanized antibody, in patients with acute myeloid leukemia (PubMed)

Phase I clinical study of RG7356, an anti-CD44 humanized antibody, in patients with acute myeloid leukemia RG7356, a recombinant anti-CD44 immunoglobulin G1 humanized monoclonal antibody, inhibits cell adhesion and has been associated with macrophage activation in preclinical models. We report results of a phase I dose-escalation study of RG7356 in relapsed/refractory acute myeloid leukemia (AML).Eligible patients with refractory AML, relapsed AML after induction chemotherapy, or previously

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2016 Oncotarget

148. Effects of Anti-β2-Glycoprotein I Antibody on the Expression of Toll-like Receptors mRNA in Choriocarcinoma and Primary Trophoblast Cells. (PubMed)

Effects of Anti-β2-Glycoprotein I Antibody on the Expression of Toll-like Receptors mRNA in Choriocarcinoma and Primary Trophoblast Cells. To investigate the effects of the anti- β2-glycoprotein I (anti-β2-GPI) antibody on the tro- phoblast by evaluating the effects of the anti-β2-GPI antibody on the expression of toll-like receptor (TLR) mRNA in choriocarcinoma cells and primary trophoblast cells.We cul- tured the choriocarcinoma cells (BeWo) and the pri- mary first trimester tropho- blast (...) with the IgGs taken from anti-β2-GPI antibody-positive and -negative sera. Four hours later we purified the RNAs from those cells. We measured the expressions of TLR mRNA in cells using real-time. PCR.The expression of TLR mRNA increased in BeWo cells and primary trophoblast cells cultured with the IgGs taken from anti-β2-GPI antibody-positive women. Specifically, the expression of TLR1, 2, and 4 in BeWo cells -and TLRI, 3, 4, and 9 in first trimester trophoblast cells increased significantly.The anti-β2

2016 Journal of Reproductive Medicine

149. Role of anti-domain 1-β<sub>2</sub> glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome: reply. (PubMed)

Role of anti-domain 1-β2 glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome: reply. 27477454 2018 02 22 2018 12 02 1538-7836 14 10 2016 10 Journal of thrombosis and haemostasis : JTH J. Thromb. Haemost. Role of anti-domain 1-ß 2 glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome: reply. 2078-2080 10.1111/jth.13428 De Craemer A-S AS Coagulation Laboratory, Department of Clinical Chemistry (...) , Microbiology and Immunology, Ghent University Hospital, Ghent, Belgium. Devreese K M J KM Coagulation Laboratory, Department of Clinical Chemistry, Microbiology and Immunology, Ghent University Hospital, Ghent, Belgium. katrien.devreese@uzgent.be. eng Letter Comment 2016 09 02 England J Thromb Haemost 101170508 1538-7836 0 Antibodies, Anticardiolipin 0 Antibodies, Antiphospholipid 0 Autoantibodies 0 Glycoproteins 0 beta 2-Glycoprotein I IM J Thromb Haemost. 2016 Oct;14 (10 ):2076-2078 27455394 J Thromb

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2016 Journal of Thrombosis and Haemostasis

150. Role of anti-domain 1-ß2glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome: comment. (PubMed)

Role of anti-domain 1-ß2glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome: comment. 27455394 2018 02 22 2018 12 02 1538-7836 14 10 2016 10 Journal of thrombosis and haemostasis : JTH J. Thromb. Haemost. Role of anti-domain 1- β 2 glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome: comment. 2076-2078 10.1111/jth.13425 Zhang S S Department of Rheumatology and Clinical Immunology, Key Laboratory (...) Support, Non-U.S. Gov't Comment 2016 09 01 England J Thromb Haemost 101170508 1538-7836 0 Antibodies, Anticardiolipin 0 Antibodies, Antiphospholipid 0 Autoantibodies 0 Glycoproteins 0 beta 2-Glycoprotein I IM J Thromb Haemost. 2016 Sep;14 (9):1779-87 27314634 J Thromb Haemost. 2016 Oct;14 (10 ):2078-2080 27477454 Antibodies, Anticardiolipin Antibodies, Antiphospholipid Antiphospholipid Syndrome Autoantibodies Glycoproteins Humans beta 2-Glycoprotein I 2016 07 06 2016 07 11 2016 10 28 6 0 2018 2 23 6 0

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2016 Journal of Thrombosis and Haemostasis

151. Pneumococcal Polysaccharide Vaccination Elicits IgG Anti-A/B Blood Group Antibodies in Healthy Individuals and Patients with Type I Diabetes Mellitus (PubMed)

Pneumococcal Polysaccharide Vaccination Elicits IgG Anti-A/B Blood Group Antibodies in Healthy Individuals and Patients with Type I Diabetes Mellitus Blood group antibodies are natural antibodies that develop early in life in response to cross-reactive environmental antigens in the absence of antigen encounter. Even later in life structural similarities in saccharide composition between environmental antigens such as bacterial polysaccharides and blood group A/B antigens could lead to changes (...) in serum levels, IgM/IgG isotype, and affinity maturation of blood group anti-A/B antibodies. We addressed the question whether immunization with pneumococcal polysaccharide (PnP) vaccine Pneumo 23 Vaccine "Pasteur Merieux" (Pn23) could have such an effect in patients with type I diabetes mellitus (DM I), an autoimmune disease where an aberrant immune response to microbial antigens likely plays a role.Anti-PnP IgM and IgG responses were determined by ELISA, and the DiaMed-ID Micro Typing System

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2016 Frontiers in immunology

152. [Phase I study of anti-EGFR monoclonal antibody (CMAB009) in patients with advanced cancer]. (PubMed)

[Phase I study of anti-EGFR monoclonal antibody (CMAB009) in patients with advanced cancer]. To characterize the safety profiles and serum pharmacokinetic effects of anti-epidermal growth factor receptor monoclonal antibody (CMAB009) in advanced cancer patients and evaluate the preliminary evidence of its anti-tumor activity.This phase I, single-center clinical trial had 2 phases of treatment: single-dose phase, followed by a fixed weekly dose. Subjects meeting the inclusion criteria were

2016 Zhonghua yi xue za zhi

153. First Phase I human clinical trial of a killed whole-HIV-1 vaccine: demonstration of its safety and enhancement of anti-HIV antibody responses (PubMed)

First Phase I human clinical trial of a killed whole-HIV-1 vaccine: demonstration of its safety and enhancement of anti-HIV antibody responses Vaccination with inactivated (killed) whole-virus particles has been used to prevent a wide range of viral diseases. However, for an HIV vaccine this approach has been largely negated due to inherent safety concerns, despite the ability of killed whole-virus vaccines to generate a strong, predominantly antibody-mediated immune response in vivo. HIV-1 (...) -infected human T lymphocytes in vitro nor in the participating volunteers receiving SAV001 vaccine. Furthermore, SAV001 with adjuvant significantly increased the pre-existing antibody response to HIV-1 proteins. Antibodies in the plasma of vaccinees were also found to recognize HIV-1 envelope protein on the surface of infected cells as well as showing an enhancement of broadly neutralizing antibodies inhibiting tier I and II of HIV-1 B, D, and A subtypes.The killed whole-HIV vaccine, SAV001, is safe

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2016 Retrovirology

154. Phase I study of Nivolumab, an anti-PD-1 antibody, in patients with malignant solid tumors (PubMed)

Phase I study of Nivolumab, an anti-PD-1 antibody, in patients with malignant solid tumors Background This study evaluated the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of single and multiple doses of nivolumab in Japanese patients with malignant solid tumors. Subjects and Methods This was an open-label, dose-escalation study in 17 patients with advanced solid tumors with a life expectancy of ≥3 months. Patients were observed for 3 weeks after a single dose

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2016 Investigational new drugs

155. The Presence of Pretransplant Antiphospholipid Antibodies IgA Anti-β-2-Glycoprotein I as a Predictor of Graft Thrombosis After Renal Transplantation. (PubMed)

The Presence of Pretransplant Antiphospholipid Antibodies IgA Anti-β-2-Glycoprotein I as a Predictor of Graft Thrombosis After Renal Transplantation. Vessel thrombosis is a severe complication after renal transplantation. Antibodies anti-β-2 glycoprotein-I of IgA isotype (IgA-aB2GP1) have been linked to thrombotic events and mortality in hemodialysis patients.All kidney transplanted patients from 2000 to 2011 (n = 1375) in our hospital were followed up for 2 years, evaluating 3 time periods.At (...) with asystolic donors.Notably, IgA-aB2GP1 was an independent risk factor for graft thrombosis (odds ratio, 5.047; P < 0.001). Furthermore, the presence of IgA-aB2GP1 was associated with early graft loss and delayed graft function. Mortality at 24 months was also higher in group 1.In conclusion, pretransplant IgA-aB2GP1 was the main risk factor for graft thrombosis and early graft loss. Further research should be made on whether anticoagulation in antibody-positive patients could ameliorate this catastrophic

2016 Transplantation

156. The prevalence of ANA antibodies, anticentromere antibodies, and anti-cyclic citrullinated peptide antibodies in patients with primary Sjögren’s syndrome compared to patients with dryness symptoms without primary Sjögren’s syndrome confirmation (PubMed)

patients were divided into two groups: I - with diagnosed pSS (N = 75); and II - with dryness without pSS evidence (N = 38). Diagnostics: indirect immunofluorescence (IF; Hep-2 cell line) of antinuclear antibodies (ANA), anti-SS-A anti-SS-B antibodies determined with semi-quantitative method, autoantibody profile (14 antigens, ANA Profil 3 EUROLINE); basic laboratory, ophthalmic examination tests, minor salivary gland biopsy with focus score (FS), joint and lung evaluation, and ESSDAI questionnaire (...) (pSS activity).88% of group I had ANA antibodies (1 : 320 titre), 5.3% at 1 : 160. Anti-SS-A antibodies were present in 88% of group I, including all ANA 1 : 160. Anti-SS-A antibodies positively correlated with greater and moderate activity of ESSDAI 5 (p = 0.046) and FS. The presence of SS-B antibodies significantly affected disease activity. ACPA present: group I - 13% (associated with higher arthritis incidence; p = 0.003); group II - 8%. ACA antibodies present in 4% of group I, but not in group

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2017 Reumatologia

157. Phase I study of tomuzotuximab, a glycoengineered therapeutic antibody against the epidermal growth factor receptor, in patients with advanced carcinomas (PubMed)

Phase I study of tomuzotuximab, a glycoengineered therapeutic antibody against the epidermal growth factor receptor, in patients with advanced carcinomas Changes in glycosylation of the constant domain (Fc) of monoclonal antibodies (mAbs) enhance antibody-dependent cell-mediated cytotoxicity independently of downstream effects following receptor blockade by the antibody, thus extending their indication. We investigated the safety, pharmacokinetics, pharmacodynamics and antitumour activity (...) of tomuzotuximab, an IgG1 glycoengineered mAb against the epidermal growth factor receptor with enhanced tumour cytotoxicity in a phase I dose-escalation study (NTC01222637).Forty-one patients with advanced solid tumours refractory to standard therapies received tomuzotuximab weekly (12-1370 mg) or two-weekly (990 mg) on a three-plus-three dose escalation design.A maximum tolerated dose was not reached. The most frequent treatment-related adverse events were infusion-related reactions in 31 (76%) patients

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2018 ESMO open

158. An anti-ASCT2 monoclonal antibody suppresses gastric cancer growth by inducing oxidative stress and antibody dependent cellular toxicity in preclinical models (PubMed)

An anti-ASCT2 monoclonal antibody suppresses gastric cancer growth by inducing oxidative stress and antibody dependent cellular toxicity in preclinical models Glutamine is a major nutrient for cancer cells during rapid proliferation. Alanine-serine-cysteine (ASC) transporter 2 (ASCT2; SLC1A5) mediates glutamine uptake in a variety of cancer cells. We previously reported that KM8094, a novel anti-ASCT2 humanized monoclonal antibody, possesses anti-tumor efficacy in gastric cancer patient-derived (...) ASCT2 showed glutamine-dependent cell growth, which was repressed by KM8094. We found that KM8094 inhibited the glutamine uptake, leading to the reduction of glutathione (GSH) level and the elevation of oxidative stress. KM8094 suppressed the cell cycle progression and increased the apoptosis. Furthermore, KM8094 exerted antibody dependent cellular cytotoxicity (ADCC) against human gastric cancer cells in vitro. Finally, in vivo studies revealed that KM8094 suppressed tumor growth in several gastric

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2018 American journal of cancer research

159. Epigenetic priming of both tumor and NK cells augments antibody-dependent cellular cytotoxicity elicited by the anti-PD-L1 antibody avelumab against multiple carcinoma cell types (PubMed)

Epigenetic priming of both tumor and NK cells augments antibody-dependent cellular cytotoxicity elicited by the anti-PD-L1 antibody avelumab against multiple carcinoma cell types Checkpoint inhibitors targeting the PD-1/PD-L1 axis are promising immunotherapies shown to elicit objective responses against multiple tumor types, yet these agents fail to benefit most patients with carcinomas. This highlights the need to develop effective therapeutic strategies to increase responses to PD-1/PD-L1 (...) blockade. Histone deacetylase (HDAC) inhibitors in combination with immunotherapies have provided preliminary evidence of anti-tumor effects. We investigated here whether exposure of either natural killer (NK) cells and/or tumor cells to two different classes of HDAC inhibitors would augment (a) NK cell‒mediated direct tumor cell killing and/or (b) antibody-dependent cellular cytotoxicity (ADCC) using avelumab, a fully human IgG1 monoclonal antibody targeting PD-L1. Treatment of a diverse array

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2018 Oncoimmunology

160. Anti-C1 Domain Antibodies That Accelerate Factor VIII Clearance Contribute to Antibody Pathogenicity in a Murine Hemophilia A Model. (PubMed)

Anti-C1 Domain Antibodies That Accelerate Factor VIII Clearance Contribute to Antibody Pathogenicity in a Murine Hemophilia A Model. Essentials Inhibitor formation remains a challenging complication of hemophilia A care. The Bethesda assay is the primary method used for determining bleeding risk and management. Antibodies that block factor VIII binding to von Willebrand factor can increase FVIII clearance. Antibodies that increase clearance contribute to antibody pathogenicity.Background (...) The development of neutralizing anti-factor VIII (FVIII) antibodies remains a challenging complication of modern hemophilia A care. In vitro assays are the primary method used for quantifying inhibitor titers, predicting bleeding risk, and determining bleeding management. However, other mechanisms of inhibition are not accounted for in these assays, which may result in discrepancies between the inhibitor titer and clinical bleeding symptoms. Objectives To evaluate FVIII clearance in vivo as a potential

2018 Journal of Thrombosis and Haemostasis

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