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Preclinical Assessment of Efficacy and Safety Analysis of CAR-T Cells (ISIKOK-19) Targeting CD19-Expressing B-Cells for the First Turkish Academic Clinical Trial with Relapsed/Refractory ALL and NHL Patients

This study reports the preclinical validation of ISIKOK-19 CD19 CAR-T cells for a Turkish clinical trial. Using G-Rex 100M for expansion and BX-795 to enhance transduction, researchers produced effective CAR-T cells that eliminated tumors in vivo, demonstrating a robust and cost-effective manufacturing process.
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Publications

Direct Delivery of piggyBac CD19 CAR T Cells Has Potent Anti-tumor Activity against ALL Cells in CNS in a Xenograft Mouse Model

This study evaluates the efficacy of intracerebroventricular (i.c.v.) delivery of piggyBac CD19 CAR T cells for CNS ALL. I.c.v. delivery eliminated CNS leukemia in mice, whereas intravenous delivery had only partial effects. The study supports direct CNS delivery as a potential therapeutic strategy.
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Publications

Allogeneic FLT3 CAR T Cells with an Off-Switch Exhibit Potent Activity against AML and Can Be Depleted to Expedite Bone Marrow Recovery

This study evaluates allogeneic FLT3 CAR T cells with a safety off-switch for AML. Expanded in G-Rex plates, these cells showed potent antileukemic activity. The off-switch allowed depletion of CAR T cells to mitigate myelotoxicity and enable bone marrow recovery, supporting clinical development.
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Publications

Engineered IL-21 Cytokine Muteins Fused to Anti-PD-1 Antibodies Can Improve CD8+ T Cell Function and Anti-tumor Immunity

This study presents a bifunctional fusion protein combining anti-PD-1 antibody with an engineered IL-21 mutein. Using G-Rex for cell culture, the fusion protein demonstrated targeted IL-21 delivery to PD-1+ T cells, enhancing cytotoxicity and tumor control in mice while minimizing off-target effects.
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Publications

Oncolytic adenovirus shapes the ovarian tumor microenvironment for potent tumor-infiltrating lymphocyte tumor reactivity

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.
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Publications

The Art and Science of Selecting a CD123-Specific Chimeric Antigen Receptor for Clinical Testing

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.
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Publications

RELY-30: Phase I Study of Relapsed CD30 Expressing Lymphoma Treated with CD30 CAR T Cells

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.
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Publications

Anti-CD30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma

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.
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Publications

CRISPR-Mediated Base Conversion Allows Discriminatory Depletion of Endogenous T Cell Receptors for Enhanced Synthetic Immunity

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.
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Publications

COBRA™: a highly potent conditionally active T cell engager engineered for the treatment of solid tumors

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.
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Publications

A serum-free protocol for the ex vivo expansion of Cytokine-Induced Killer cells using gas-permeable static culture

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.
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Publications

Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients

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.
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