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811 Cord blood HSC-derived NK Cells: a potent platform for allogeneic immunotherapy
BackgroundNatural killer (NK) cells offer a promising allogeneic immunotherapy for various malignancies due to their innate ability to target tumor cells via a balance of activating and inhibitory receptors. This mechanism enables effective antitumor activity with minimal toxicity. However, clinical translation has been hindered by challenges including: limited scalability of cell sources for manufacturing, significant donor-to-donor variability, and the need for robust, predictive preclinical assays.MethodsWe developed a scalable NK cell manufacturing and screening platform leveraging IBR403, a proprietary small molecule, to expand hematopoietic stem cells (HSCs) from small-volume cord blood segments (≤300 µL) by 1,000- to 1,000,000-fold, while preserving the main 25 mL cord blood unit (CBU) for selective large-scale production. Expanded HSCs (xHSCs) were differentiated into NK cells (xHSC-NKs) and functionally characterized using flow cytometry, xCELLigence assays, and advanced models including serial tumor rechallenge, 3D organoid co-culture, and in vivo studies.ResultsxHSC-NKs from optimal donors expressed high levels of activating receptors (e.g., NKG2D, DNAM-1), degranulated efficiently, and secreted proinflammatory cytokines upon stimulation—mirroring peripheral blood NK (pbNK) function. These xHSC-NKs exhibited potent cytotoxicity across diverse tumor cell lines, enabling identification of high-performing donor profiles across various hematological and solid tumor types. In serial rechallenge assays, xHSC-NKs displayed variable responses based on donor origin, highlighting the importance of functional prescreening. xHSC-NKS also eliminated patient-derived 3D tumor organoids comparably to pbNKs. Additionally, xHSC-NKs acquired a mature phenotype (KIR+CD16+) and exhibited long-term persistence and high killing capacity after 10 weeks in vivo.ConclusionsOur platform enables robust expansion and differentiation of CBU-derived HSCs into highly functional NK cells, supporting scalable, cost-effective production. With integrated prescreening and long-term in vivo efficacy, xHSC-NKs represent a powerful allogeneic cell therapy platform with the potential to deliver durable antitumor responses and broaden patient access to NK-based immunotherapies.
Journal Article
The end of the beginning : cancer, immunity, and the future of a cure
\"A fascinating history of our understanding and the treatment of cancer by one of the leading figures in the field--who is also a pioneer on the cusp of a breakthrough.\"--Provided by publisher.
Book
The basics of cancer immunotherapy
\"This book provides patients and their physicians (especially \"non-oncologist\" health care providers) with a clear and concise introduction to cancer immunotherapy, which, unlike traditional forms of cancer therapy, acts by boosting the patient's own immune system to fight cancer. The unique features of cancer immunotherapy make its management, monitoring and side-effects different from those of traditional cancer therapy. Especially novel are the side effects of cancer immunotherapy, necessitating greater awareness for both patients and physicians in order to minimize complications of therapy. The patient-friendly, concise, easy-to-understand, and up-to-date knowledge presented in this book will inform patients about the benefits and risks of cancer immunotherapy, and help them and their care providers to understand how immunotherapy would control their unique disease. Researchers and academic professionals in the field of cancer immunotherapy will also find clear and useful information to help them communicate with patients or address unresolved problems. Some key features of the book are:Expertise. All editors and authors are scientists and oncologists specializing in cancer immunotherapy, and are involved in scientific discovery from the early stage of immune-checkpoint inhibitors to today's daily patient care. Their insights, expertise and experience guarantee the high quality and authority in the science, medicine and practice of cancer immunotherapy. Patient-friendly. This book is written for cancer patients in order to meet their needs when considering immunotherapy. As an educational tool, this book will help the reader balance the risks and benefits based on both science and clinical facts, and therefore to make the best choice in receiving or withdrawing from immunotherapy. Disease Specificity. Cancer is a complicated disease involving multiple stages and pathology. Its response to immunotherapy is individualized and varies depending on cancer types. The authors' expertise in treating different types of cancers, including melanoma, lung, kidney, bladder, and lymphoma, provides disease-specific insights in applying immunotherapy to each disease.\"-- Provided by publisher.
Book
Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma
A phase 3 trial of BCMA-specific CAR T cells in relapsed and refractory myeloma showed an advantage over standard therapy (progression-free survival, 13.3 vs. 4.4 months); 39% of patients in the ide-cel group had a complete response.
Journal Article
The lock and key of medicine : monoclonal antibodies and the transformation of healthcare
This book is the first to tell the extraordinary yet unheralded history of monoclonal antibodies. Often referred to as Mabs, they are unfamiliar to most nonscientists, yet these microscopic protein molecules are everywhere, quietly shaping our lives and healthcare. Discovered in the mid-1970s in the laboratory where Watson and Crick had earlier unveiled the structure of DNA, Mabs have radically changed understandings of the pathways of disease. They have enabled faster, cheaper, and more accurate clinical diagnostic testing on a vast scale. And they have played a fundamental role in pharmaceutical innovation, leading to such developments as recombinant interferon and insulin, and personalized drug therapies such as Herceptin. Today Mabs constitute six of the world's top ten blockbuster drugs and make up a third of new introduced treatments. -- From dust jacket.
Book
Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma
In an analysis of the primary outcome of this phase 3 trial, patients with early relapsed or refractory large B-cell lymphoma who received axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor T-cell therapy, as second-line treatment had significantly longer event-free survival than those who received standard care. Data were needed on longer-term outcomes.
In this trial, we randomly assigned patients with early relapsed or refractory large B-cell lymphoma in a 1:1 ratio to receive either axi-cel or standard care (two to three cycles of chemoimmunotherapy followed by high-dose chemotherapy with autologous stem-cell transplantation in patients who had a response). The primary outcome was event-free survival, and key secondary outcomes were response and overall survival. Here, we report the results of the prespecified overall survival analysis at 5 years after the first patient underwent randomization.
A total of 359 patients underwent randomization to receive axi-cel (180 patients) or standard care (179 patients). At a median follow-up of 47.2 months, death had been reported in 82 patients in the axi-cel group and in 95 patients in the standard-care group. The median overall survival was not reached in the axi-cel group and was 31.1 months in the standard-care group; the estimated 4-year overall survival was 54.6% and 46.0%, respectively (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.54 to 0.98; P = 0.03 by stratified two-sided log-rank test). This increased survival with axi-cel was observed in the intention-to-treat population, which included 74% of patients with primary refractory disease and other high-risk features. The median investigator-assessed progression-free survival was 14.7 months in the axi-cel group and 3.7 months in the standard-care group, with estimated 4-year percentages of 41.8% and 24.4%, respectively (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). No new treatment-related deaths had occurred since the primary analysis of event-free survival.
At a median follow-up of 47.2 months, axi-cel as second-line treatment for patients with early relapsed or refractory large B-cell lymphoma resulted in significantly longer overall survival than standard care. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.).
Journal Article