mosunetuzumab clinical trials

Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab at the previously determined recommended phase II dose (RP2D). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). Background: Mosunetuzumab is a novel CD20/CD3 bispecific anti- body that directs T-cells to engage and eliminate malignant B-cells. clinical-trials@chugai-pharm.co.jp: 試験に関する問い合わせ先 Contact for Public Queries . Her last clinical trial at The University of Pennsylvania (CAR T-Cell - Novartis CTL019) saved her life, and in October of 2016, she became a seven-time cancer survivor. The overall response rate (ORR) was 68% (42/62), with 31 pts (50%) achieving CR (Figure). A phase 2 clinical trial (NCT03563716) is evaluating its use alone or in combination with Atezolizumab (anti-PD-1L) in chemotherapy-naïve patients with locally advanced or metastatic non. Ending Trials Early. - investigational material (s) 薬剤 . Upper Tract Urothelial Carcinoma represents the first book of its kind to be dedicated solely to UTUC. Bartlett:BMS/Celgene: Research Funding; Merck: Research Funding; Kite, a Gilead Company: Research Funding; Immune Design: Research Funding; Janssen: Research Funding; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Millennium: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Consultancy, Research Funding; Affimed Therapeutics: Research Funding; Autolus: Research Funding; Acerta: Consultancy; Roche/Genentech: Consultancy, Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; BTG: Consultancy; ADC Therapeutics: Consultancy; Forty Seven: Research Funding. Kim:Mundipharma: Research Funding; Donga: Research Funding; Kyowa Kirn: Research Funding; Celltrion: Research Funding; JJ: Research Funding; Pfizer: Research Funding; F. Hoffmann-La Roche: Research Funding. The JULIET trial, based on Penn's initial clinical trial, led by Director of the Lymphoma Program, Stephen Schuster, MD, included 27 sites in 10 countries across North America, Europe, Australia, and Asia. Mosunetuzumab is a fully humanised, full-length, IgG1 bispecific antibody targeting CD20 antigen and CD3 antigen, being developed by Genentech, a subsidiary of Mosunetuzumab - Genentech - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript . Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712097. Conclusions: Fixed-duration mosunetuzumab monotherapy results in high response rates and durable disease control with a tolerable safety profile in heavily pretreated patients with FL, including known high-risk subgroups. This book systematically reviews the most important findings on cancer immune checkpoints, sharing essential insights into this rapidly evolving yet largely unexplored research topic. Anal Chim Acta. US Clinical Trials Registry; Clinical Trials Nct Page; Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell . Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This is a unique book focusing on the management of rare sarcomas, which pose an important challenge in Europe and in the US, as they represent nearly one quarter of all new diagnoses of cancer and have lower survival rates than common ... Apply online instantly. 一般的名称等 - 試験対象薬剤等 generic name etc. Posting id: 675476125. The median PFS was 11.8 months (95% CI: 7.3-21.9 months). Gastroenter., Pododdz. Adequate hematologic function (unless due to underlying lymphoma, per the investigator). Follicular Lymphoma Market Insights. Mogamulizumab resulted in a longer PFS than vorinostat (median 7.7 months vs. 3.1 months). GO29781 (NCT02500407) is an ongoing open-label, multicenter, Phase I/Ib, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab in pts with relapsed/refractory (R/R) B-cell lymphoma. Immune Rebalancing: The Future of Immunosuppression summarizes the most promising perspectives of immunopharmacology, in particular in the area of immunosuppression by considering molecular pathways, personalized medicine, microbiome and ... The reader can find under this one volume virtually all types of existing and emerging tumor models in use by the research community. This book provides a deeper insight on how these newer models could de-risk modern drug discovery. Cancer Clinical Trials. This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. Penuel:Genentech, Inc./ F. Hoffmann-La Roche: Current Employment; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. The NHL virtual population was used to project range of clinical IL6 peaks after the first dose of Cycle 1 for a range of clinically tested doses of mosunetuzumab (0.05-2.8 mg). . Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. In October 2018 she entered a clinical trial that was evaluating an entirely different way to train her immune system to destroy tumor cells. This is a comprehensive textbook of Hodgkin's and non-Hodgkin's lymphomas written by leaders in the field of childhood lymphomas. It includes clinical, pathologic and molecular biology of each subtype of lymphoma. The most frequently reported (>10% of pts) grade (Gr) 3 or higher AEs included hypophosphatemia (23%; transient and clinically asymptomatic) and neutropenia (21%; with a low rate of febrile neutropenia [2%]). z o. o.; Oddział Hematologii i Transplantologii Szpiku, Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Szpital Kliniczny; Oddzial Hematologii i Transplantacji Szpiku, Instytut Hematologii i Transfuzjologii; Klinika Hematologii, Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, FSBI "National Medical Research Center of Oncology N.N. A very sad moment for us all. 簡易な試験の名称 public title. Use the hyperlinks, where available to access additional clinical trial information. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication . Mosunetuzumab is a full-length, fully humanized immunoglobulin G1 CD20/CD3 bispecific antibody that redirects T cells to engage and eliminate malignant B cells. A phase I clinical trial is evaluating mosunetuzumab for the treatment of hematologic tumors. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Follows SOPs and strategies to manage and retain research subjects. CK is affiliated with the Roche Innovation Center Zurich, holds stocks and has patents with Hoffmann-La Roche company. Search for other works by this author on: © 2020 by The American Society of Hematology, Copyright ©2020 by American Society of Hematology, 623.Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma-Clinical Studies, https://doi.org/10.1182/blood-2020-135839. Apply for a PAREXEL Clinical Research Associate II (CRA) - Midwest job in Belmont, CA. Data from the study were presented during the virtual 2020 American Society of Hematology Annual Meeting. Although BTK and PLCγ2 mutations have been found to be associated with ibrutinib resistance in a fair percentage of CLL patients, no information on resistance mechanisms is available in patients lacking these mutations. Amy was still determined to get her lymphoma under control. Create a FREE ClinicalConnection.com member account and be notified when clinical trials that match your health interests become available in your area. Interim results from an ongoing, open-label, multicentre, phase 1/1b As the clinical sites' sole point of contact, this includes addressing and . For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). Clinical Trials Nct Page A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len) or Glofitamab + Len With or Without Obinutuzumab; and Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With R/R Follicular Lymphoma Study authors reported relationships with Genentech, which sponsored the trial. The interesting part of these particular antibodies is that they target multiple different markers on the cell surface. Neurologic AEs (NAEs; defined by any AEs reported as Preferred Terms in SOC Nervous System Disorders and SOC Psychiatric Disorders) were observed in 28 pts (45%); all were Gr 1 (n=18) or 2 (n=10). The outcomes of a handful of requests for accelerated assessment at the European Medicines Agency appear not yet to be in the public domain. Mosunetuzumab (RG7828) is a full-length, fully humanized immunoglobulin G1 (IgG1) bispecific antibody targeting both CD3 (on the surface of T cells) and CD20 (on the surface of B cells). Talk with your doctor and family members or friends about deciding to join a study. Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Mosun monotherapy has a manageable safety profile and promising efficacy, including durable complete responses (CR), in patients (pts) with relapsed and/or refractory (R/R) non . Trial Identifiers. ICH GCP. Most advanced is the anti-CD20/CD3 Mosunetuzumab (RG7828 . Found inside – Page 16Many more CAR T-cell products are in development and a number have entered late-stage clinical trials. ... (CD19/CD3) and 16 mosunetuzumab (CD20/CD3), and antibody–drug conjugates such as brentuximab–vedotin and loncastuximab–tesirine. DelveInsight's 'Follicular Lymphoma - Market Insights, Epidemiology, and Market Forecast - 2030' report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of Follicular Lymphoma in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. Diefenbach:Trillium: Research Funding; Millenium/Takeda: Research Funding; Merck: Consultancy, Research Funding; MEI: Research Funding; LAM Therapeutics: Research Funding; Incyte: Research Funding; Genentech, Inc.: Consultancy, Research Funding; Denovo: Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding. Establish themselves as a reliable, trusted resource of . Negricea:F. Hoffmann-La Roche: Current Employment. . Individual Participant Data (IPD) Sharing Statement: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). (Cycle length = 28 days for Cycles 1-12), Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11, Relapsed or Refractory Follicular Lymphoma. Table 40: Mosunetuzumab, Clinical Trial Description, 2021 Table 41: Odronextamab, Clinical Trial . Non-myeloablative allogeneic stem cell transplantation (also known as mini-transplantation or reduced-intensity conditioning transplantation) is a major advance in the field of hematopoietic transplantation within the last 5 years. No Gr ≥3 NAEs or serious NAEs were reported. Contact for Public Queries Name: Clinical trials information. Introduction: Follicular lymphoma (FL) is considered an indolent yet incurable disease characterized by recurrent relapses: disease-free intervals shorten, and refractoriness increases with each relapse. Shadman:Fred Hutchinson / University of Washington: Current Employment; Abbvie, Genentech, Inc., AstraZeneca, Sound Biologics , Pharmacyclics, Verastem, ADC therapeutics, Beigene, Cellectar, BMS, Mophosys and Atara Biotherapeutics: Consultancy; Mustang Bio, Celgene, Pharmacyclics, Gilead, Genentech, Inc., Abbvie, TG therapeutics, Beigene, AstraZeneca, Sunesis: Research Funding.