Cell Therapies Core

细胞疗法核心

基本信息

批准号：
10333175
负责人：
Daniel Abate-Daga
金额：
$ 16.22万
依托单位：
H. LEE MOFFITT CANCER CTR & RES INST
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-02-18 至 2027-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10333175
关键词：
Accreditation Advisory Committees American Biological Assay Biotechnology CLIA certified Cancer Center Support Grant Catalogs Cell Therapy Cells Cellular immunotherapy Chemistry Clinical Clinical Trials Competence Complex Contracts Data Dendritic Cells Dendritic cell tumor Development Dose E-learning Effector Cell Ensure Evaluation Florida Foundations Gene-Modified Generations Goals Grant Hematologic Neoplasms Hematopoietic stem cells Hour Human Immune Immunity Immunotherapy Institutional Review Boards Investigational Drugs Laboratories Laboratory Procedures Lead Manufacturer Name Mission Natural Killer Cells Nature Pathologist Patients Peer Review Performance Policies Postdoctoral Fellow Procedures Protocols documentation Publications Quality Control Recombinant DNA Reporting Research Research Personnel Review Committee Rotation Scientist Services Solid Stem cell transplant System Tissues Training Training Activity Training Programs Translations Tumor-Infiltrating Lymphocytes United States Food and Drug Administration Universities Vaccines Validation Viral Vector Work assay development base cancer immunotherapy career chimeric antigen receptor chimeric antigen receptor T cells college engineered stem cells genetic approach immunotherapy clinical trials lectures manufacturing facility manufacturing process meetings member neoplastic cell new technology novel pre-clinical programs research and development scale up stem cells transgene expression

项目摘要

PROJECT SUMMARY CELL THERAPIES CORE The Cell Therapies Core (CTC) enables research, development and manufacturing of human cells for use in patients undergoing cell-based immunotherapies for cancer. CTC manufactures cell products that support novel, investigator-initiated clinical trials (IITs), while maintaining compliance with standards set by the Food and Drug Administration, the Foundation for the Accreditation of Cellular Therapies, and by other accrediting bodies. CTC supports Members in all stages of clinical trial development, and execution, including collaborative work enabling investigational new drug filing, development and validation of manufacturing processes, and quality control assays for clinical release, as well as full scale clinical manufacturing for patients on clinical trials. CTC also aids Members in drafting and submitting cell therapy-related grants or contracts. CTC supports Members by organizing its activities into four Specific Aims: Aim 1: To develop new technologies for translation of cellular therapies. Aim 2: To provide regulatory assistance in support of cellular therapies. Aim 3: To produce the highest quality cellular products for immunotherapy clinical trials. Aim 4: To educate and train scientists and clinicians committed to careers in cellular therapies. CTC has significantly contributed to high impact research of FDA-approved IITs by providing dendritic cell and tumor cell-based vaccines, gene-modified stem and progenitor cells, T regulatory cells, natural killer cells, tumor-infiltrating lymphocytes (TIL), and chimeric antigen receptor (CAR) T cells. Since 2016, CTC Member usage has increased by 63%. Specifically, CTC has supported 26 Members (67% peer reviewed) across three CCSG Programs (MM 24%, HOB 3%, IO 73%), resulting in support of 53 protocols (a 96% increase since 2016) and the manufacture of 450 cellular products. Together, this Member activity represented 97% of all CTC usage over the last reporting period. The expertise of CTC is consistent with its mission to fully support clinical trials evaluating ex vivo selection and expansion of cells, transgene expression, stem cell engineering, and genetic strategies that augment immunity and/or effectively treat solid and hematologic cancers. To maximize CTC’s capacity to meet projected Member needs over the next five years, CTC is expanding its physical footprint, adding 8,300-ft2 of space that will enable CTC to provide automated, closed-system manufacturing of cellular products in a class 100,000 space, and to increase manufacturing capacity in its current class 10,000 laboratory spaces. Furthermore, CTC will expand its repertoire of unique services to also include the generation of viral vectors necessary for the development of cell-based therapies, such as CAR-T and TIL based therapies, reducing a critical developmental bottleneck and meeting Member needs.

项目概要细胞疗法核心细胞疗法核心 (CTC) 能够研究、开发和制造用于以下领域的人体细胞： CTC 生产支持癌症的细胞产品。新颖的、研究者发起的临床试验 (IIT)，同时保持符合食品和药物管理局制定的标准和药物管理局、细胞疗法认证基金会以及其他认证机构 CTC 在临床试验开发和执行的各个阶段为会员提供支持，包括协作工作使研究性新药备案、开发和生产验证成为可能临床放行的流程和质量控制测定，以及全面的临床生产 CTC 还帮助会员起草和提交与细胞治疗相关的资助或申请。 CTC 通过将其活动组织成四个具体目标来支持会员：目标 1：开发细胞疗法转化的新技术。目标 2：提供监管援助以支持细胞疗法。目标 3：生产用于免疫治疗临床试验的最高质量的细胞产品。目标 4：教育和培训致力于细胞疗法事业的科学家和精神病学家。 CTC 通过提供树突状细胞和基于肿瘤细胞的疫苗、基因修饰干细胞和祖细胞、T 调节细胞、自然杀伤细胞、肿瘤浸润淋巴细胞 (TIL) 和嵌合抗原受体 (CAR) T 细胞自 2016 年起，CTC 成员。具体而言，CTC 为三个成员中的 26 名成员（67% 经同行评审）提供了支持。 CCSG 计划（MM 24%、HOB 3%、IO 73%），支持 53 个协议（自推出以来增加了 96%） 2016）以及 450 种细胞产品的制造，该会员活动占所有活动的 97%。上一个报告期间 CTC 的使用情况与其全力支持的使命是一致的。评估细胞的离体选择和扩增、转基因表达、干细胞工程、以及增强免疫力和/或有效治疗实体癌和血液癌的遗传策略。为了最大限度地提高 CTC 的能力，满足未来五年预计的会员需求，CTC 正在扩大其物理占地面积，增加 8,300 平方英尺的空间，使 CTC 能够提供自动化的封闭系统在 100,000 级空间中制造蜂窝产品，并提高其制造能力现有的 10,000 个实验室空间此外，CTC 还将扩大其独特的服务范围。包括生成开发基于细胞的疗法（例如 CAR-T）所需的病毒载体和基于 TIL 的疗法，减少关键的发展瓶颈并满足会员的需求。