Cell Therapies Core

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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.