Publications
Adoptive Transfer of NKG2D CAR mRNA-Engineered Natural Killer Cells in Colorectal Cancer Patients
Clinical trial of mRNA-engineered NKG2D CAR-NK cells in metastatic colorectal cancer. NK cells were expanded from PBMCs using K562 feeder cells in G-Rex 100 vessels. Treatment was safe and showed tumor regression in local injection sites.
Publications
PROCESSES FOR PRODUCTION OF TUMOR INFILTRATING LYMPHOCYTES AND USES OF SAME IN IMMUNOTHERAPY
Patent describing the Gen 2 manufacturing process for TILs. Detailed methods include the use of G-Rex 100M and G-Rex 500M for the Rapid Expansion Protocol (REP) to shorten culture time and improve efficiency compared to the Gen 1 process.
Publications
Repurposing endogenous immune pathways to tailor and control chimeric antigen receptor T cell functionality
Study on gene editing T cells to place CAR and IL-12P70 under endogenous control (TRAC, IL2Ra, PDCD1). TRACCAR T cells were expanded in G-Rex 10 devices. The engineered cells showed regulated cytokine secretion and improved anti-tumor activity.
Publications
Universal Ready-to-Use Immunotherapeutic Approach for the Treatment of Cancer: Expanded and Activated Polyclonal γδ Memory T Cells
This study develops a protocol for expanding polyclonal γδ memory T cells using artificial antigen-presenting cells in G-Rex. The method yields large numbers of potent, non-alloreactive T cells with broad anti-tumor activity. This platform supports the creation of off-the-shelf immunotherapies.
Publications
Iovance Gen 2 TIL Manufacturing Process Produces Drug Products that Exhibit Favorable Quality Attributes for Adoptive Cell Transfer Across 5 Solid Tumor Indications
Poster describing the Iovance Gen 2 TIL manufacturing process which utilizes G-Rex for the Rapid Expansion Protocol (REP). Data shows success across melanoma, cervical, HNSCC, sarcoma, and lung cancers with high viability and T-cell purity.
Publications
Lifileucel, a Potential Therapy for Metastatic Melanoma Patients who are Primary Refractory to Prior Anti-PD-1 Therapy
Clinical data on Lifileucel (LN-144) for metastatic melanoma. The manufacturing process involves a 22-day protocol using G-Rex. Shows 40.5% ORR in primary refractory patients.
Publications
NK cells expressing a chimeric activating receptor eliminate MDSCs and rescue impaired CAR-T cell activity against solid tumors
NKG2D.zeta-NK cells were generated and expanded in G-Rex devices. These cells eliminated myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment, enhancing the infiltration and efficacy of GD2.CAR-T cells in neuroblastoma models.
Publications
Mycobacteria-Specific T Cells May Be Expanded From Healthy Donors and Are Near Absent in Primary Immunodeficiency Disorders
Mycobacteria-specific T cells (MSTs) were expanded from healthy donors using peptide pools and G-Rex 10. The protocol yielded polyfunctional CD4+ T cells. MSTs were largely absent in patients with primary immunodeficiencies.
Publications
Rapid Transduction and Expansion of Transduced T Cells with Maintenance of Central Memory Populations
Describes a 9-day protocol for generating CAR-T cells from rhesus macaque PBMCs. G-Rex 6-well plates were used for the expansion phase (days 5-9). The method produced high numbers of viable cells with a central memory phenotype suitable for infusion.
Publications
Immunologic Recognition of a Shared p53 Mutated Neoantigen in a Patient with Metastatic Colorectal Cancer
Report on a patient with metastatic colorectal cancer treated with TILs targeting a p53 mutation. TILs were screened and expanded using G-Rex 100. Although specific T-cells were identified, clinical response was limited due to loss of HLA heterozygosity in the tumor.
Publications
Phase II clinical trial of adoptive cell therapy for patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and low-dose interleukin-2
A Phase II study evaluating low-dose IL-2 with TILs for metastatic melanoma. 12 patients treated with non-myeloablative chemotherapy and TILs expanded in G-Rex100. Two partial responses and one unconfirmed PR were observed. Low-dose IL-2 was feasible but resulted in lower response rates compared to high-dose regimens.
Publications
Overcoming Challenges in Process Development of Cellular Therapies
A review of CAR T-cell process development challenges. It highlights G-Rex as an alternative to bags, capable of supporting high T-cell numbers (~20x10^9) and adaptable to automated harvesting systems.