Systematic Review of Available CAR-T Cell Trials around the World.
Ontology highlight
ABSTRACT:
SUBMITTER: Barros LRC
PROVIDER: S-EPMC9179563 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
Publications
Systematic Review of Available CAR-T Cell Trials around the World.
Barros Luciana Rodrigues Carvalho LRC Couto Samuel Campanelli Freitas SCF da Silva Santurio Daniela D Paixão Emanuelle Arantes EA Cardoso Fernanda F da Silva Viviane Jennifer VJ Klinger Paulo P Ribeiro Paula do Amaral Costa PDAC Rós Felipe Augusto FA Oliveira Théo Gremen Mimary TGM Rego Eduardo Magalhães EM Ramos Rodrigo Nalio RN Rocha Vanderson V
Cancers 20220527 11
In this systematic review, we foresee what could be the approved scenario in the next few years for CAR-T cell therapies directed against hematological and solid tumor malignancies. China and the USA are the leading regions in numbers of clinical studies involving CAR-T. Hematological antigens CD19 and BCMA are the most targeted, followed by mesothelin, GPC3, CEA, MUC1, HER2, and EGFR for solid tumors. Most CAR constructs are second-generation, although third and fourth generations are being lar ...[more]
Similar Datasets
Project description:AimsWith a prevalence of 16%, diabetes mellitus (DM) is one of the most frequent non-communicable comorbidities of tuberculosis (TB). DM is a major risk factor for adverse TB outcomes and may require personalized TB drug dosing regimens. However, information on the inclusion of DM in TB drug trials is lacking. We aimed to assess the percentage of recent TB drug efficacy trials that included DM patients.MethodsA systematic review was performed and reported according to PRISMA guidelines. PubMed, Science Direct, and ClinicalTrials.gov databases were systematically searched for TB drug trials published between 1 January 2012 and 12 September 2017. Primary outcome was the percentage of TB drug trials performed around the world that included DM patients.ResultsOut of the included 41 TB drug trials, 12 (29.3%) reported DM comorbidity among the study participants. Nine trials (21.9%) excluded all patients with DM comorbidity, ten (24.4%) excluded only insulin-dependent or uncontrolled DM, and 10 (24.4%) did not mention whether DM was included or excluded. Of the 12 trials that included DM comorbidity, the majority did not report the diagnostic criteria for DM and none reported outcomes in the DM subpopulation. Inclusion of DM was higher in drug-resistant-TB trials (67%, P = .003, vs drug-susceptible) and trials performed in Asia (60%, P = .006, vs Africa).ConclusionsFewer than 1/3 recent TB drug trials reported the inclusion of DM. To better reflect real-world DM prevalence and differential TB drug effectiveness, inclusion of DM patients requires increased attention for future TB drug trials.
| S-EPMC6595305 | biostudies-literature
Project description:The development of Chimeric Antigen Receptor T cells therapy initiated by the United States and China is still currently led by these two countries with a high number of clinical trials, with Europe lagging in launching its first trials. In this systematic review, we wanted to establish an overview of the production of CAR-T cells in clinical trials around the world, and to understand the causes of this delay in Europe. We particularly focused on the academic centers that are at the heart of research and development of this therapy. We counted 1087 CAR-T cells clinical trials on ClinicalTrials.gov (Research registry ID: reviewregistry1542) on the date of 25 January 2023. We performed a global analysis, before analyzing the 58 European trials, 34 of which sponsored by academic centers. Collaboration between an academic and an industrial player seems to be necessary for the successful development and application for marketing authorization of a CAR-T cell, and this collaboration is still cruelly lacking in European trials, unlike in the leading countries. Europe, still far behind the two leading countries, is trying to establish measures to lighten the regulations surrounding ATMPs and to encourage, through the addition of fundings, clinical trials involving these treatments.
| S-EPMC9954171 | biostudies-literature
Project description:T-cell receptor-engineered T-cell therapy and chimeric antigen receptor T-cell therapy are 2 types of adoptive T-cell therapy that genetically modify natural T cells to treat cancers. Although chimeric antigen receptor T-cell therapy has yielded remarkable efficacy for hematological malignancies of the B-cell lineages, most solid tumors fail to respond significantly to chimeric antigen receptor T cells. T-cell receptor-engineered T-cell therapy, on the other hand, has shown unprecedented promise in treating solid tumors and has attracted growing interest. In order to create an unbiased, comprehensive, and scientific report for this fast-moving field, we carefully analyzed all 84 clinical trials using T-cell receptor-engineered T-cell therapy and downloaded from ClinicalTrials.gov updated by June 11, 2018. Informative features and trends were observed in these clinical trials. The number of trials initiated each year is increasing as expected, but an interesting pattern is observed. NY-ESO-1, as the most targeted antigen type, is the target of 31 clinical trials; melanoma is the most targeted cancer type and is the target of 33 clinical trials. Novel antigens and underrepresented cancers remain to be targeted in future studies and clinical trials. Unlike chimeric antigen receptor T-cell therapy, only about 16% of the 84 clinical trials target against hematological malignancies, consistent with T-cell receptor-engineered T-cell therapy's high potential for solid tumors. Six pharma/biotech companies with novel T-cell receptor-engineered T-cell ideas and products were examined in this review. Multiple approaches have been utilized in these companies to increase the T-cell receptor's affinity and efficiency and to minimize cross-reactivity. The major challenges in the development of the T-cell receptor-engineered T-cell therapy due to tumor microenvironment were also discussed here.
| S-EPMC6391541 | biostudies-literature
Project description:Excess salt intake contributes to hypertension and increased cardiovascular disease risk. Efforts to implement effective salt-reduction strategies require accurate data on the sources of salt consumption. We therefore performed a systematic review to identify the sources of dietary salt around the world. We systematically searched peer-reviewed and gray literature databases for studies that quantified discretionary (salt added during cooking or at the table) and nondiscretionary sources of salt and those that provided information about the food groups contributing to dietary salt intake. Exploratory linear regression analysis was also conducted to assess whether the proportion of discretionary salt intake is related to the gross domestic product (GDP) per capita of a country. We identified 80 studies conducted in 34 countries between 1975 and 2018. The majority (n = 44, 55%) collected data on dietary salt sources within the past 10 y and were deemed to have a low or moderate risk of bias (n = 75, 94%). Thirty-two (40%) studies were judged to be nationally representative. Populations in Brazil, China, Costa Rica, Guatemala, India, Japan, Mozambique, and Romania received more than half of their daily salt intake from discretionary sources. A significant inverse correlation between discretionary salt intake and a country's per capita GDP was observed (P < 0.0001), such that for every $10,000 increase in per capita GDP, the amount of salt obtained from discretionary sources was lower by 8.7% (95% CI: 5.1%, 12%). Bread products, cereal and grains, meat products, and dairy products were the major contributors to dietary salt intake in most populations. There is marked variation in discretionary salt use around the world that is highly correlated with the level of economic development. Our findings have important implications for the type of salt-reduction strategy likely to be effective in a country.
| S-EPMC7231587 | biostudies-literature
Project description:Barriers to access abortion services globally have led to the development of alternative methods to assist and support women who seek an abortion. One such method is the use of hotlines, currently utilised globally for abortion care. This review aimed to understand (1) how abortion hotlines facilitate access to abortion; and (2) how women and stakeholders describe the impact of hotlines on abortion access. Published quantitative and qualitative studies and grey literature were systematically reviewed alongside an identification and description of abortion hotlines in the public domain. Our findings highlight that the existence of abortion hotlines is highly context-dependent. They may exist either as an independent community-based model of care, or as part of formal care pathways within the health system. Hotlines operating in contexts with legal restrictions seem to be broader in scope and will use innovative approaches to adapt to their setting and reach hard-to-reach populations. All the abortion hotlines that provided information on a data extraction form used evidence-based guidelines but women seeking medical abortion still struggle to access quality medications. There is limited data in general on abortion hotlines, especially on the user and provider experience. Abortion hotlines have the potential to facilitate access to safe abortion care through evidence-based information and to decrease maternal mortality and morbidity from unsafe abortions for women and girls globally.
| S-EPMC8097399 | biostudies-literature
Project description:To date global research on depression has used assessment tools based on research and clinical experience drawn from Western populations (i.e., in North American, European and Australian). There may be features of depression in non-Western populations which are not captured in current diagnostic criteria or measurement tools, as well as criteria for depression that are not relevant in other regions. We investigated this possibility through a systematic review of qualitative studies of depression worldwide. Nine online databases were searched for records that used qualitative methods to study depression. Initial searches were conducted between August 2012 and December 2012; an updated search was repeated in June of 2015 to include relevant literature published between December 30, 2012 and May 30, 2015. No date limits were set for inclusion of articles. A total of 16,130 records were identified and 138 met full inclusion criteria. Included studies were published between 1976 and 2015. These 138 studies represented data on 170 different study populations (some reported on multiple samples) and 77 different nationalities/ethnicities. Variation in results by geographical region, gender, and study context were examined to determine the consistency of descriptions across populations. Fisher's exact tests were used to compare frequencies of features across region, gender and context. Seven of the 15 features with the highest relative frequency form part of the DSM-5 diagnosis of Major Depressive Disorder (MDD). However, many of the other features with relatively high frequencies across the studies are associated features in the DSM, but are not prioritized as diagnostic criteria and therefore not included in standard instruments. The DSM-5 diagnostic criteria of problems with concentration and psychomotor agitation or slowing were infrequently mentioned. This research suggests that the DSM model and standard instruments currently based on the DSM may not adequately reflect the experience of depression at the worldwide or regional levels.
| S-EPMC5488686 | biostudies-literature
Project description:IntroductionGlobally, over one million cardiac operations occur each year, whereas cardiac surgery is expensive and largely inaccessible without insurance or philanthropic support. Substantial cost variation has been reported within cardiac surgery in the United States and among non-cardiac surgical procedures globally, but little is known on the global procedural cost variation for common adult cardiac surgical procedures.Objectives and significanceThis review seeks to assess variation in procedural costs of coronary artery bypass grafting (CABG), mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures between and within countries. Results may give insights in the scope and drivers of cost variation around the world, posing cost reduction lessons. Results may further inform the potential of economies of scale in reducing procedural costs, benefiting patients, hospitals, governments, and insurers.Methods and analysisA systematic review will be performed using the EconLit, Embase, PubMed/MEDLINE, Web of Science, and WHO Global Index Medicus databases to identify articles published between January 1, 2000 and June 1, 2020. Studies describing procedural costs for CABG, mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures will be identified. Articles describing other types of cardiac surgery, concomitant aortic surgery, only describing costs related to non-surgical care, or with incomplete cost data will be excluded from the analysis. No exclusion will be based solely on article type or language. Identified costs will be converted to 2019 USD to account for local currency unit inflation and exchange fluctuations.Ethics and disseminationThis study protocol has been prospectively registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols. This review requires no institutional review board approval. Results of this study will be summarized and disseminated in a peer-review journal.
| S-EPMC7417884 | biostudies-literature
Project description:ObjectiveTo quantify progress with the initiation of salt reduction strategies around the world in the context of the global target to reduce population salt intake by 30% by 2025.MethodsA systematic review of the published and grey literature was supplemented by questionnaires sent to country program leaders. Core characteristics of strategies were extracted and categorised according to a pre-defined framework.ResultsA total of 75 countries now have a national salt reduction strategy, more than double the number reported in a similar review done in 2010. The majority of programs are multifaceted and include industry engagement to reformulate products (n = 61), establishment of sodium content targets for foods (39), consumer education (71), front-of-pack labelling schemes (31), taxation on high-salt foods (3) and interventions in public institutions (54). Legislative action related to salt reduction such as mandatory targets, front of pack labelling, food procurement policies and taxation have been implemented in 33 countries. 12 countries have reported reductions in population salt intake, 19 reduced salt content in foods and 6 improvements in consumer knowledge, attitudes or behaviours relating to salt.ConclusionThe large and increasing number of countries with salt reduction strategies in place is encouraging although activity remains limited in low- and middle-income regions. The absence of a consistent approach to implementation highlights uncertainty about the elements most important to success. Rigorous evaluation of ongoing programs and initiation of salt reduction programs, particularly in low- and middle- income countries, will be vital to achieving the targeted 30% reduction in salt intake.
| S-EPMC4511674 | biostudies-literature
Project description:BackgroundTaenia solium cysticercosis is a zoonotic neglected disease responsible for severe health disorders such as seizures and death. Understanding the epidemiology of human cysticercosis (HCC) in endemic regions will help to expose critical information about the transmission of the disease, which could be used to design efficient control programs. This review gathered serological data on apparent prevalence of T. solium circulating antigens and/or seroprevalence of T. solium antibodies, apparent prevalence of human taeniasis and risk factors for HCC from endemic communities in order to understand the differences in exposure to the parasite and active infections with T. solium metacestodes in endemic areas around the world.MethodsThree databases were used to search sero-epidemiological data from community-based studies conducted between 1989 and 2014 in cysticercosis endemic communities worldwide. The search focused on data obtained from T. solium circulating antigen detection by monoclonal antibody-based sandwich ELISA and/or T. solium antibody seroprevalence determined by Enzyme-linked Immunoelectrotransfer Blot (EITB). A meta-analysis was performed per continent.Principal findingsA total of 39,271 participants from 19 countries, described in 37 articles were studied. The estimates for the prevalence of circulating T. solium antigens for Africa, Latin America and Asia were: 7.30% (95% CI [4.23-12.31]), 4.08% (95% CI [2.77-5.95]) and 3.98% (95% CI [2.81-5.61]), respectively. Seroprevalence estimates of T. solium antibodies were 17.37% (95% CI [3.33-56.20]), 13.03% (95% CI [9.95-16.88]) and 15.68% (95% CI [10.25-23.24]) respectively. Taeniasis reported prevalences ranged from 0 (95% CI [0.00-1.62]) to 17.25% (95% CI [14.55-20.23]).SignificanceA significant variation in the sero-epidemiological data was observed within each continent, with African countries reporting the highest apparent prevalences of active infections. Intrinsic factors in the human host such as age and immunity were main determinants for the occurrence of infections, while exposure was mostly related to environmental factors which varied from community to community.
| S-EPMC4493064 | biostudies-literature
Project description:Chimeric antigen receptor-modified (CAR) T cells targeting CD19 have revolutionized the treatment of relapsed or refractory aggressive B-cell lymphomas, and their use has increased the cure rate for these cancers from 10 to 40%. Two second-generation anti-CD19 CAR T-cell products, axicabtagene ciloleucel and tisagenlecleucel, have been approved for use in patients, and the approval of a third product, lisocabtagene maraleucel, is expected in 2020. The commercial availability of the first two products has facilitated the development of real-world experience in treating relapsed or refractory aggressive B-cell lymphomas, shed light on anti-CD19 CAR T-cell products' feasibility in trial-ineligible patients, and raised the need for strategies to mitigate the adverse effects associated with anti-CD19 CAR T-cell therapy, such as cytokine release syndrome, neurotoxicity, and cytopenia. In addition, promising clinical data supporting the use of anti-CD19 CAR T-cell therapy in patients with indolent B-cell lymphomas or chronic lymphocytic leukemia have recently become available, breaking the paradigm that these conditions are not curable. Multiple clinical CAR T-cell therapy-based trials are ongoing. These include studies comparing CAR T-cell therapy to autologous stem cell transplantation or investigating their use at earlier stages of disease, novel combinations, and novel constructs. Here we provide a thorough review on the use of the anti-CD19 CAR T-cell products axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel in patients with indolent or aggressive B-cell lymphoma or with chronic lymphocytic leukemia, and present novel CAR T cell-based approaches currently under investigation in these disease settings.
| S-EPMC7326110 | biostudies-literature