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This document outlines the protocol for the RELY-30 Phase I study evaluating CD30 CAR T cells in relapsed CD30+ lymphoma. It details patient eligibility, treatment plans, and safety monitoring. The protocol aims to assess the safety and efficacy of CAR T cells following lymphodepleting chemotherapy.

This study compares five CD123-CAR constructs to select a candidate for clinical trials in AML. Using G-Rex plates for expansion, researchers identified a CD28.CD28z CAR with superior expression and function. This construct was selected for a phase 1 clinical study targeting relapsed/refractory AML.

This research demonstrates that oncolytic adenovirus coding for TNFa and IL-2 remodels the ovarian tumor microenvironment. TILs expanded in G-Rex plates showed enhanced antitumor reactivity against autologous tumors treated with the virus. The strategy offers a promising combinatorial approach for ovarian cancer.

This report describes COBRA, a conditionally active bispecific T cell engager for solid tumors. Human T cells expanded using G-Rex technology were used to test the efficacy of COBRA in vivo. The study demonstrates complete tumor regression in mice, highlighting the potential of this protease-activated therapy.

This study utilizes CRISPR base editing to disrupt endogenous TCRs while expressing a hepatitis B-specific recombinant TCR. Cells expanded in G-Rex showed high purity and enhanced functional avidity. This approach enables the production of potent, off-the-shelf TCR-T cells for treating HCC.

This phase I/II study evaluates autologous CD30 CAR-T cells in relapsed/refractory Hodgkin lymphoma. Fludarabine-based lymphodepletion led to high response rates and durability. The therapy was safe with no neurotoxicity. The study highlights the potential of CD30 CAR-Ts for heavily pretreated patients.

This phase 2 trial evaluates virus-specific T cells (VSTs) for treating BK polyomavirus in transplant recipients. Manufactured in G-Rex devices, donor-derived and third-party VSTs demonstrated high response rates for viremia and hemorrhagic cystitis with minimal toxicity, offering a safe therapy for BKPyV.

This study presents a serum-free protocol for expanding Cytokine-Induced Killer (CIK) cells using G-Rex devices. The method reduced manipulation while yielding high cell numbers with a naive-like phenotype. G-Rex cultures supported efficient expansion and cytotoxic activity, suitable for clinical manufacturing.

This study assesses the safety of piggyBac transposon-mediated hGMR-CAR T cells in a non-human primate model. Using G-Rex for expansion, researchers generated autologous CAR T cells that showed potent killing in vitro and no overt toxicity in vivo, supporting the safety of this approach for clinical trials.

This book chapter details the use of G-Rex technology for large-scale cell expansion. It covers protocols for G-Rex plates and closed systems, optimization of seeding and feeding, and harvesting. It highlights the linear scalability of the platform for CAR-T and NK cell production.

This review describes the AIM platform, which uses nanoparticle-based artificial APCs to generate antigen-specific T cells. The enrichment and expansion (E+E) process, utilizing G-Rex culture systems, produces consistent, high-quality memory CD8+ T cells for clinical adoptive cell therapy applications.

This study introduces T-CEP, a soluble activator for T cell expansion. G-Rex 24-well plates were used for the 12-day expansion period. T-CEP stimulation favored the growth of CD8+CD27+ T cells, a phenotype associated with better persistence and clinical outcomes.