magrolimab clinical trials

hypericin), Patients administered a live vaccine within 28 days prior to enrollment. I. Following a section on tissue culture, chromosome staining and basic information about karyotyping, this text presents nomenclature and quality standards, as well as protocols of relevance to comprehensive cytogenetic diagnostics. Individual Participant Data (IPD) Sharing Statement: NCI is committed to sharing data in accordance with NIH policy. This textbook provides a clinically oriented, compact and up-to-date overview on infections in hematology patients and their management. I. After surgery, these patients continue receiving magrolimab and dinutuximab every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Clinical Trials Nct Page; Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer II. 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. CD47 blockade can also enhance cross-priming of T cells. A DLT is defined as any Grade 3 or greater adverse event (AE) that is assessed as related to at least 1 study drug that occurs during the 5-week DLT Assessment Period, defined as the first 5 weeks of treatment for each participant. AML is a type of cancer that starts in the bone marrow and can quickly move to the blood and other parts of the body. (650) 522-2739 Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome -- Ongoing Clinical Program Includes the Phase 3 ENHANCE Study in MDS -- -- Additional Studies Are Evaluating Magrolimab in Both Hematologic and Solid Tumors -- Evaluate the overall response rate (ORR) of patients in the NBL cohorts (measurable R/R NBL and evaluable R/R NBL) and osteosarcoma patients (measurable relapsed osteosarcoma) in the expansion cohorts treated at the RP2D. For patients with the TP53 mutation, 69% (n=20/29) achieved a response, 45% (n=13/29) achieved a CR and 14% (n=4/29) achieved a CRi. Evaluate the event free survival (EFS) in two cohorts of patients who are treated at the recommended phase 2 dose (RP2D) (measurable relapsed osteosarcoma and patients with pulmonary relapse undergoing resection) and compare to historical controls. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Starting in Cycle 2, magrolimab 30 mg/kg will be given every 2 weeks. Prior organ transplantation requiring immunosuppression or active autoimmune disease. Despite the high unmet need in this patient population, azacitidine (AZA) is the only approved therapy for HR-MDS that has improved OS in clinical trials to date. Found insideIn this book, world-renowned experts in the field express well-reasoned opinions on a range of issues and controversies relating to haploidentical transplantation with the aim of providing practicing hematologists with clinically relevant ... This book provides an unprecedented overview of "Targeted Therapies" for acute myeloid leukemias. Blocking CD47 with magrolimab may enable the body's immune system to find and destroy the cancer cells. Found insideThis book will allow readers to discover the crucial role of tumor microenvironment (TME) in the selection of cancer cells that are more prone to carry on cancer initiation and progression. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Safety data will be analyzed per standard methods and interpreted descriptively. Response rates will be calculated for the measurable neuroblastoma cohort whose best response is a CR or PR. Determine the recommended phase 2 dose (RP2D) of Hu5F9-G4 (magrolimab) given in combination with dinutuximab in children and young adults. Why Should I Register and Submit Results? (973) 517-0519. Clinical trials; Locations; Stanford Health Care; Stanford Children's Health; Emergency Department; Dial 911 in the event of a medical emergency; Explore Health Care. Anti-magrolimab antibody positivity will be assessed at pre-study drug (magrolimab and avelumab) infusion Day 1 for Cycles 1, 2, 3 and 4, and then every third cycle after Cycle 4 until Cycle 13, End of Treatment (EOT) (up to Cycle 13 + 14 days), and Safety Follow-up Visit (SFU) (30 days ± 7 days after last dose of magrolimab). Magrolimab is a monoclonal antibody that may interfere with the ability of … Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558139. Approximately 20,000 Americans will be diagnosed with AML each year. You have reached the maximum number of saved studies (100). To explore biomarkers of response in the tumor microenvironment through multiplexed ion beam imaging (MIBI) on resected tissue or archival tissues including comparison of pre- and post- treatment tumor tissues from patients undergoing staged resection of pulmonary osteosarcoma. Determine the pharmacokinetics (PK) of Hu5F9-G4 (magrolimab) in children and young adults. RBC transfusions are permitted during the screening period and prior to enrollment, Patients with known inherited or acquired bleeding disorders are not eligible, Patients with prior hemolytic anemia or Evans syndrome in the last 3 months, Patients with significant medical diseases that would worsen the risk-benefit ratio of participating in this study. Availability of pre-treatment tumor tissue to evaluate programmed cell death-ligand 1(PD-L1) expression. 4. Marian Cutler, Media Based on Dose Limiting Toxicities (DLTs) assessment in Dose Level 1 Cycle 1; additional participants will be enrolled and administered Dose Level 2. The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus time. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. I. The median DOR was 7.6 months (range: 0.03+ to 15.1+ months) and the minimum residual disease (MRD) negativity in patients with a CR/CRi was 29% (n=5/17). Patients had received a median of four prior therapies, and 95% had disease that was resistant to rituximab. “We continue to be encouraged by the response rates seen in this study and are rapidly advancing the development of magrolimab based on its potential to help address significant unmet medical needs,” said Daejin Abidoye, Senior Vice President, Head of Oncology, Gilead Sciences. Treatment discontinuation due to drug-related AE occurred in 4.7% of all patients. Mark Chao, M.D., Ph.D., cofounder of Forty Seven, Inc. and current VP of oncology clinical research at Gilead Sciences. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov (NCT03248479). At least 14 days must have elapsed after receiving pegfilgrastim, At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic non-myelosuppressive regimen, At least 4 weeks must have elapsed since prior therapy with 131I-MIBG, Monoclonal antibodies: At least 3 weeks must have elapsed since prior therapy that included a monoclonal antibody, Patients who have received prior therapy with GD2 antibodies, regardless of response to therapy, will be eligible, At least 7 days must have elapsed since the last pharmacologic dose of systemic steroids, Eastern Cooperative Oncology Group (ECOG) performance status =< 2; Subjects > 16 years of age: Karnofsky >= 50%; Subjects =< 16 years of age: Lansky scale >= 50%, Hemoglobin >= 9.5 g/dL, transfusion support acceptable, Platelets >= 100,000/mcL, independent of transfusions, Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) for age (sum of conjugated and unconjugated), Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN, Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2, Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial, For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated, Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Found inside – Page iImmunotherapy is a rapidly evolving field that mandates frequent revision of the book as new insights to fight cancer emerge. III. Clinical Trials / Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer. The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall … The book highlights work from many different labs that taught us abnormal HDACs potentially contribute to the development or progression of many human diseases including immune dysfunctions, heart disease, cancer, memory impairment, aging, ... Gilead’s ongoing Phase 1b trial (NCT03248479) is evaluating the safety, tolerability, and efficacy of treatment with magrolimab in combination with azacitidine in untreated patients with AML who are ineligible for induction chemotherapy. What's New in this Edition: * Key points summarizing each chapter. * Expanded section on principles of immunology. * Completely rewritten chapter on infectious diseases. * Updates throughout to reflect current standards and other ... Patients were then treated with full doses of azacitidine and a magrolimab maintenance dose of 30 mg/kg once weekly or every two weeks. Individuals with symptomatic or untreated central nervous system (CNS) metastases. Clinical Trials. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. ClinicalTrials.gov Identifier: NCT04751383, Interventional The company strives to transform and simplify care for people with life-threatening illnesses around the world. All patients in the trial received a magrolimab 1 mg/kg priming dose, coupled with intrapatient dose escalation, to mitigate on-target anemia.  (Clinical Trial), Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma, Experimental: Arm A (magrolimab, dinutuximab), Experimental: Arm B (magrolimab, dinutuximab, surgery), Philadelphia, Pennsylvania, United States, 19104, Contact: Site Public Contact    267-425-5544. Found insideThis book deals with the rapid progress in the area of myelodysplastic syndromes (MDS). MDS are a group of age-associated heterogeneous malignant bone marrow stem cell disorders. Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV). Please remove one or more studies before adding more. The authors review physiological resistance based upon tumor architecture, cellular resistance based on drug transport, epigenetic changes that neutralize or bypass drug cytotoxicity, and genetic changes that alter drug target molecules by ... Most patients were cytopenic at baseline, and no significant increased cytopenias, infections or immune-related adverse events (AEs) were observed in the study. ARM A: Patients receive magrolimab intravenously (IV) over 2 hours on days 1, 8, and 15 of cycles 1-2 and days 1 and 15 of subsequent cycles, and dinutuximab IV over 10 hours on days 2-5. In addition, this trial may help researchers find out if it is safe to give magrolimab and dinutuximab after surgery to remove tumors from the lungs. Talk with your doctor and family members or friends about deciding to join a study. Cycle 1 length is 35 days and Cycles 2-13 length is 28 days. Gilead Sciences, Inc. 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