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Clinical Trial News

SeaStar Medical Receives FDA Breakthrough Device Designation for Novel Therapy

SeaStar Medical has been granted a Breakthrough Device Designation by the FDA for its Selective Cytopheretic Device (SCD), aimed at treating acute kidney injury (AKI) in adults. This designation facilitates an expedited regulatory review for the upcoming pivotal clinical trial of the SCD, which targets hyperinflammation by selectively addressing activated neutrophils and monocytes.

FDA Grants Breakthrough Therapy Designation to Trastuzumab Deruxtecan for HER2-Low Metastatic Breast Cancer

  • The FDA has granted breakthrough therapy designation to trastuzumab deruxtecan (Enhertu) for treating adults with unresectable or metastatic HER2-low breast cancer who have received prior systemic therapy.
  • The designation is based on results from the phase 3 DESTINY-Breast04 trial, which demonstrated significant improvements in progression-free survival and overall survival in this patient population.
  • This represents the first trial to show that HER2-directed therapy can benefit patients with HER2-low expression, potentially changing diagnostic and treatment paradigms for breast cancer.
  • The multicenter study enrolled 557 patients with HER2-low breast cancer, randomizing them 2:1 to receive either trastuzumab deruxtecan or physician's choice of chemotherapy.

Six-Monthly Injection Shows Promise as Alternative to Daily Blood Pressure Medication in Global Trial

  • Queen Mary University of London is leading a global trial testing a six-monthly injection as an alternative to daily blood pressure tablets for hypertension treatment.
  • The study involves 630 patients worldwide, including 100 from the UK, and is funded by Alnylam Pharmaceuticals with support from the National Institute for Health and Care Research.
  • Researchers hope the subcutaneous injection could provide a more convenient treatment option for the estimated one-third of UK adults who have high blood pressure.
  • If successful, the treatment could offer significant benefits for patients who currently require daily medication to reduce their risk of heart attacks and strokes.

Dual-Targeting CAR-T Therapies Show Promise in Overcoming B-Cell Cancer Treatment Resistance

  • Researchers at University Hospitals Seidman Cancer Center developed a novel BAFF CAR-T therapy that targets three receptors (BAFF-R, BCMA, TACI) instead of one, potentially reducing antigen escape seen in CD19-only therapies.
  • A separate bispecific CAR-T therapy (LV20.19) targeting both CD20 and CD19 achieved a 90% overall response rate in a phase 1/2 trial for relapsed/refractory B-cell non-Hodgkin lymphoma.
  • The BAFF CAR-T approach may cause less severe B-cell aplasia compared to CD19 therapies since BAFF receptors are not expressed by early-stage B-cells.
  • Both therapies represent significant advances in addressing treatment resistance and improving outcomes for patients with B-cell malignancies.

Current Clinical Trials in Traumatic Brain Injury

A comprehensive review of clinical trials for traumatic brain injury (TBI) highlights the ongoing search for effective treatments, focusing on drugs like amantadine, botulinum toxin A, and tranexamic acid. Despite numerous trials, the variability in study outcomes underscores the need for careful trial design and patient stratification.
NCT04280965CompletedEarly Phase 1
The University of Texas Health Science Center at San Antonio
Posted 2/1/2019
NCT00973674CompletedPhase 2
University of Texas Southwestern Medical Center
Posted 7/1/2009
NCT00623506CompletedNot Applicable
Durham VA Medical Center
Posted 1/1/2008
NCT01750268CompletedPhase 4
University of California, San Francisco
Posted 11/1/2012
NCT01673828CompletedPhase 2
Michael A. Rogawski, MD, PhD
Posted 4/1/2013
NCT00453921CompletedNot Applicable
Dartmouth-Hitchcock Medical Center
Posted 2/1/2007
NCT04303065Unknown StatusPhase 3
Hospital Son Espases
Posted 7/24/2020
NCT01014403CompletedPhase 1
University of Texas Southwestern Medical Center
Posted 11/1/2009
NCT04400266RecruitingPhase 4
Massachusetts General Hospital
Posted 8/1/2020
NCT02990091WithdrawnPhase 2
University of Pennsylvania
Posted 1/1/2017
NCT01990768CompletedPhase 2
University of Washington
Posted 5/1/2015
NCT01342549CompletedPhase 3
VA Office of Research and Development
Posted 9/1/2011
NCT02407028RecruitingPhase 2
Hennepin Healthcare Research Institute
Posted 6/25/2018
NCT03061565Completed
Australian and New Zealand Intensive Care Research Centre
Posted 8/1/2017
NCT05097261RecruitingPhase 4
Geert Meyfroidt, MD, PhD
Posted 9/6/2021
NCT00957671CompletedPhase 4
The University of Texas Medical Branch, Galveston
Posted 11/1/2003
NCT02025439CompletedNot Applicable
Edward Hines Jr. VA Hospital
Posted 2/1/2014
NCT04550377RecruitingPhase 2
NYU Langone Health
Posted 5/26/2021
NCT03554265CompletedPhase 3
The University of Texas Medical Branch, Galveston
Posted 8/6/2018
NCT04099667Active, Not RecruitingPhase 2
Supernus Pharmaceuticals, Inc.
Posted 12/17/2019
NCT04006054Unknown StatusPhase 4
Xiangya Hospital of Central South University
Posted 6/6/2019
NCT02791945CompletedPhase 2
University of California, San Francisco
Posted 8/1/2016
NCT04527289CompletedPhase 4
Damanhour University
Posted 9/30/2020
NCT03559114RecruitingPhase 3
Sunnybrook Health Sciences Centre
Posted 7/19/2018
NCT04558346CompletedPhase 2
Michael Rippee
Posted 10/20/2020
NCT02255799CompletedPhase 3
Baylor College of Medicine
Posted 9/1/2013
NCT01463033CompletedPhase 2
Pavel Klein
Posted 4/1/2005
NCT01670526CompletedPhase 3
VA Office of Research and Development
Posted 12/1/2012
NCT05058677RecruitingPhase 4
The University of Texas Health Science Center, Houston
Posted 11/9/2021
NCT00779324CompletedNot Applicable
Wake Forest University Health Sciences
Posted 8/1/2009
NCT04631484CompletedPhase 3
POLYSAN Scientific & Technological Pharmaceutical Company
Posted 11/22/2020
NCT01202110TerminatedPhase 2
Cedars-Sinai Medical Center
Posted 6/1/2010
NCT04521881RecruitingPhase 3
London School of Hygiene and Tropical Medicine
Posted 4/18/2021
NCT04945213RecruitingPhase 3
Hospital Sirio-Libanes
Posted 1/10/2023
NCT04003285Not Yet RecruitingPhase 2
VA Office of Research and Development
Posted 9/1/2024
NCT04673240Unknown Status
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Posted 3/29/2019
NCT01343329WithdrawnPhase 1
Johns Hopkins University
Posted 7/1/2011
NCT01249404CompletedPhase 3
Ipsen
Posted 3/1/2011
NCT00727246CompletedPhase 2
Patricia M. Arenth
Posted 3/1/2009
NCT01313299CompletedPhase 3
Ipsen
Posted 8/1/2011
NCT03260569CompletedPhase 3
University of Cincinnati
Posted 12/12/2018
NCT04244058SuspendedEarly Phase 1
Weill Medical College of Cornell University
Posted 9/23/2020
NCT04573803Not Yet RecruitingPhase 3
Cambridge University Hospitals NHS Foundation Trust
Posted 3/1/2021
NCT04588311RecruitingPhase 3
Australian and New Zealand Intensive Care Research Centre
Posted 11/9/2020
NCT00621751CompletedNot Applicable
Wake Forest University Health Sciences
Posted 2/1/2008
NCT03982602CompletedEarly Phase 1
University of Missouri-Columbia
Posted 7/4/2019
NCT01611194CompletedPhase 2
U.S. Army Medical Research and Development Command
Posted 9/11/2012
NCT01336413CompletedPhase 2
VA Office of Research and Development
Posted 10/1/2013
NCT01048138TerminatedPhase 3
Federal University of São Paulo
Posted 1/31/2018
NCT01847755CompletedPhase 1
Barry Miskin, MD
Posted 4/1/2013
NCT04815967Active, Not RecruitingPhase 2
Supernus Pharmaceuticals, Inc.
Posted 11/16/2021
NCT04489160Unknown StatusPhase 2
Leiden University Medical Center
Posted 2/25/2021
NCT04117672RecruitingPhase 2
Peter Siesjö
Posted 3/10/2020
NCT05049057RecruitingPhase 2
Henry M. Jackson Foundation for the Advancement of Military Medicine
Posted 7/19/2022
NCT00233103CompletedPhase 2
Icahn School of Medicine at Mount Sinai
Posted 6/1/2003
NCT01760785CompletedNot Applicable
University of Colorado, Denver
Posted 9/1/2008
NCT03417492TerminatedPhase 1
University of Pennsylvania
Posted 3/1/2018
NCT02957331CompletedPhase 4
University of Tennessee
Posted 1/1/2016
NCT01856270CompletedPhase 2
University of Washington
Posted 4/1/2013
NCT01933217CompletedPhase 4
Children's Hospital Medical Center, Cincinnati
Posted 11/1/2013
NCT04427241Not Yet RecruitingPhase 4
Konkuk University Medical Center
Posted 6/1/2023
NCT01854385CompletedPhase 2
University of Washington
Posted 6/1/2013

Diet and Gut Microbiota Shape Development of Regulatory T Cells, Study Finds

  • Research reveals that diet and gut microbiota significantly influence the development of regulatory T cells (Tregs), which are crucial for immune tolerance and preventing autoimmune diseases.
  • Both dietary components and bacterial metabolites can regulate Treg differentiation through multiple mechanisms, including epigenetic changes, metabolic alterations, and receptor engagement.
  • Western diets may contribute to inflammatory diseases by disrupting normal Treg development, while dietary interventions could potentially restore Treg numbers to prevent or treat these conditions.

Novel Therapies Transform Multiple Myeloma Treatment Landscape: CAR-T, Bispecifics Lead Innovation Wave

  • Recent FDA approvals including CAR-T cell therapies ide-cel and cilta-cel, along with antibody-drug conjugate belantamab mafodotin, have significantly expanded treatment options for multiple myeloma patients.
  • Despite progress extending median survival from 2-3 years to 10-15 years, challenges remain in managing drug resistance and relapse, with emerging CELMoD oral therapies showing promise for outpatient treatment.
  • Dr. Paul Richardson highlights the strategic importance of early treatment decisions and the need for practical, community-based delivery options, particularly during the COVID-19 pandemic.

FDA Approves Sotorasib for KRAS G12C Mutated Metastatic NSCLC

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sotorasib (Lumakras™, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have received at least one prior systemic therapy. This approval is based on the results of the CodeBreaK 100 trial, showing an overall response rate of 36% among patients treated with sotorasib.

FDA Extends Review of Regeneron's REGEN-COV for COVID-19 Treatment and Prophylaxis

• The FDA has extended the review of Regeneron's BLA for REGEN-COV by three months, with a new target action date of July 13, 2022. • The extension is due to ongoing discussions with the FDA regarding pre-exposure prophylactic use, supported by additional data from a completed prophylaxis trial. • REGEN-COV is currently not authorized for use in any U.S. states, territories, or jurisdictions due to variant susceptibility. • Regeneron is developing next-generation antibodies active against current variants of concern and has initiated a first-in-human clinical trial.

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