Cell Therapies Core

细胞疗法核心

• 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
• 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

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.

项目总结 细胞疗法的核心 细胞治疗核心(CTC)使人类细胞的研究、开发和制造用于 接受癌症细胞免疫疗法的患者。CTC制造支持以下功能的电池产品 新的、由研究人员发起的临床试验(IITs)，同时保持符合Food制定的标准 和药物管理局，细胞疗法认证基金会和其他认证机构 身体。CTC在临床试验开发和执行的所有阶段为成员提供支持，包括 协作工作，使研究新药备案、开发和生产验证成为可能 临床释放的过程和质量控制分析，以及全面的临床生产 正在进行临床试验的病人。CTC还协助成员起草和提交与细胞治疗有关的赠款或 合同。反恐委员会通过将其活动组织成四个具体目标来支持成员： 目的1：开发细胞疗法翻译的新技术。 目标2：为支持细胞疗法提供监管协助。 目的3：为免疫治疗临床试验生产高质量的细胞产品。 目标4：教育和培训致力于细胞疗法事业的科学家和临床医生。 CTC通过提供树突状细胞和 肿瘤细胞疫苗，基因修饰的干细胞和祖细胞，T调节细胞，自然杀伤细胞， 肿瘤浸润性淋巴细胞(TIL)和嵌合抗原受体(CAR)T细胞。自2016年以来，反恐委员会成员 使用量增加了63%。具体地说，反恐委员会支持了26名成员(67%的同行评审)，涉及三个领域 CCSG计划(MM 24%，HOB 3%，IO 73%)，导致支持53个协议(自 2016年)和450种蜂窝产品的制造。加起来，这项会员活动占所有活动的97% 上一个报告期内的四氯化碳使用量。反恐委员会的专门知识与其充分支持 临床试验评估细胞的体外选择和扩增，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病的遗传策略。至 最大限度地提高CTC的能力以满足未来五年预计的成员需求，CTC正在扩大其 物理占用空间，增加8,300-ft2的空间，使CTC能够提供自动化、封闭的系统 在100,000级空间中制造蜂窝产品，并增加其 目前有10,000个实验室空间。此外，反恐委员会还将扩大其独特服务的范围，以 包括开发基于细胞的疗法所需的病毒载体的产生，如CAR-T 和基于TIL的疗法，减少了一个关键的发展瓶颈，满足了成员的需求。