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.

项目摘要细胞疗法核心细胞疗法核心（CTC）使人类细胞的研究，开发和制造用于接受基于细胞的癌症免疫疗法的患者。 CTC制造商支持的细胞产品新颖的研究者发动的临床试验（IIT），同时保持符合食物设定的标准和药物管理局，蜂窝疗法认证的基础以及其他认证身体。 CTC在临床试验开发和执行的各个阶段支持成员，包括协作工作，可以调查新药归档，制造和验证制造业过程和临床释放的质量控制测定法以及全尺度临床制造临床试验的患者。 CTC还帮助成员起草和提交与细胞治疗相关的补助金或合同。 CTC通过将其活动组织成四个具体目标来支持：目标1：开发用于翻译细胞疗法的新技术。目标2：提供监管辅助以支持细胞疗法。目标3：生产用于免疫疗法临床试验的最高质量的细胞产品。目标4：教育和培训致力于蜂窝疗法职业的科学家和临床医生。 CTC通过提供树突状细胞和基于肿瘤细胞的疫苗，基因修饰的茎和祖细胞，T调节细胞，天然杀伤细胞，肿瘤淋巴细胞（TIL）和嵌合抗原受体（CAR）T细胞。自2016年以来，CTC成员用法增加了63％。特别是，CTC支持了三名成员（67％的同行评审） CCSG计划（MM 24％，HOB 3％，IO 73％），从而支持53个协议（由于 2016年）和450种细胞产品的生产。这项成员活动共同占所有成员的97％在上一个报告期间的CTC使用情况。 CTC的专业知识与其完全支持的使命一致评估细胞的离体选择和扩展，转化表达，干细胞工程的临床试验，以及增强免疫学和/或有效治疗固体和血液学癌症的遗传策略。到 CTC最大化CTC满足预计会员需求的能力，CTC正在扩大其物理足迹，增加了8,300-ft2的空间，可以使CTC提供自动化的封闭系统在100,000级空间中的蜂窝产品制造，并提高其生产能力目前的10,000级实验室空间。此外，CTC将将其独特服务的曲目扩展到包括开发基于细胞的疗法所需的病毒向量的产生，例如CAR-T 和基于基于的疗法，减少关键的发展瓶颈和满足会员需求。