A5027652638- CAR-T cell therapy research
- Biomedical Ethics and Regulation
- Childhood Cancer Survivors' Quality of Life
- Acute Lymphoblastic Leukemia research
- Viral Infectious Diseases and Gene Expression in Insects
- Pharmaceutical studies and practices
- Neuroblastoma Research and Treatments
- Peptidase Inhibition and Analysis
- Cytomegalovirus and herpesvirus research
- Histone Deacetylase Inhibitors Research
- CRISPR and Genetic Engineering
- Cancer Immunotherapy and Biomarkers
- Global Health Workforce Issues
- Migration, Health and Trauma
- Child and Adolescent Health
- Integrated Circuits and Semiconductor Failure Analysis
- Social Media in Health Education
- Immune Cell Function and Interaction
- Immune Response and Inflammation
- Hematological disorders and diagnostics
- Immunotherapy and Immune Responses
- Immune cells in cancer
- Lymphoma Diagnosis and Treatment
- Economic and Financial Impacts of Cancer
United States Food and Drug Administration
2018-2025
Center for Biologics Evaluation and Research
2018-2025
National Cancer Institute
2010-2013
Georgetown University
2011-2013
MedStar Georgetown University Hospital
2013
National Institutes of Health
2010-2011
Georgetown University Medical Center
2011
Children's National
2010
Abstract In October 2017, the FDA granted regular approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for treatment of adult patients with relapsed or refractory large B-cell lymphoma after two more lines systemic therapy. Efficacy was based on complete remission (CR) rate and duration response (DOR) in 101 (median 3 prior regimens) treated single-arm trial. Patients received single infusion preceded by lymphodepleting chemotherapy...
In October 2021, the FDA approved brexucabtagene autoleucel (brexu-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). Approval was based on phase II portion ZUMA-3, single-arm, open-label, multicenter trial that evaluated single infusion brexu-cel, preceded by lymphodepleting chemotherapy cyclophosphamide and fludarabine, in this population. Efficacy...
This JAMA Insights discusses the recent FDA approval of obecabtagene autoleucel for adults with relapsed or refractory B-cell acute lymphoblastic leukemia and provides regulatory considerations.
Pediatric patient-reported outcome (PRO) data can help inform the US Food and Drug Administration's (FDA's) benefit-risk assessment of cancer therapeutics by quantifying symptom functional outcomes from patient's perspective.This study assessed use PROs in commercial pediatric oncology trials submitted to FDA for regulatory review. databases were searched identify product applications approved between 1997 2020. Sponsor-submitted documents reviewed determine whether PRO collected, which...
In March 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor T-cell therapy, for treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after at least 2 lines systemic therapy. Approval was based on ZUMA-5, single-arm, open-label, multicenter trial that evaluated single infusion preceded by lymphodepleting chemotherapy cyclophosphamide fludarabine, in this population....
Multimodality therapy consisting of surgery, chemotherapy, and radiation will fail in approximately 40% patients with pediatric sarcomas result substantial long-term morbidity those who are cured. Immunotherapeutic regimens for the treatment solid tumors typically generate antigen-specific responses too weak to overcome considerable tumor burden suppressive mechanisms need adjuvant assistance. Previous work suggests that inhibitors DASH (dipeptidyl peptidase IV activity and/or structural...
Twenty-seven pediatric residents were assessed for knowledge, attitudes, and behaviors regarding rights of immigrant families. A program documenting was reinforced in the clinic with posters individual consultations on children's needs. This brief effective instructing health nutritional services patients.
Abstract T cell depletion (TCD) of donor bone marrow (BM) reduces graft-versus-host-disease (GVHD) after allogeneic blood and transplantation (alloBMT), but can result in poor reconstitution relapse. We have shown that TCD BM deficient the gamma interferon (IFNγ) receptor allows delayed lymphocyte infusions (DLI) without GVHD. replicated these results with STAT1, which mediates IFNα IFNγ signals, demonstrated expanded plasmacytoid dendritic cells (pDCs). In this study, we further...
Abstract Introduction: Pediatric cancers have been reported to be infiltrated with macrophages. Tumor associated macrophages and myeloid derived suppressive cells (MDSCs) are increasingly recognized play an important role in cancer immune escape, promote tumor progression by suppression of adaptive immunity, poor prognosis adult cancers. Little is known about the presence these pathobiology pediatric We sought analyze sarcomas for expressing inducible nitric oxide synthase (iNOS), arginase1...