Enhanced recovery and isolation of target cells from blood samples

Abstract

The invention relates to a method and platform for producing CAR-T cells and processing biological cells within a single, functionally closed container. The method involves introducing host cells into a sealed container with multiple aseptic passages, performing genetic modification, and maintaining cells in controlled conditions monitored by real-time feedback until a desired fraction of genetically modified cells is achieved. The container also supports target cell isolation using buoyant microbubbles functionalized with antibodies or aptamers, facilitating separation of target cells from non-target cells during centrifugation. Pneumatic pressure is employed for waste separation and cell harvest, achieving high-purity cell recovery. The platform includes modules for cell enrichment, sequestration, and isolation, achieving high recovery and purity rates for therapeutic cell populations. This integrated, closed-system approach ensures aseptic conditions, efficient processing, and high-quality cell products for advanced therapeutic applications.

Description

Attorney Docket No.473.10.PCT9 ENHANCED RECOVERY AND ISOLATION OF TARGET CELLS FROM BLOOD SAMPLES Inventors: Jonathan Ellis and Philip H. Coelho Applicant: Trenchant BioSystems, Inc. RELATED APPLICATIONS

[0001] This application claims priority from the United States Provisional Application with Serial Number 63 / 616710 which was filed on December 31, 2023. The Provisional Application is hereby incorporated by reference in its entirety. TECHNICAL FIELD OF THE DISCLOSURE

[0002] This disclosure is generally related to cell therapies, and more particularly a device capable of separating target cells from non-target cells in blood or blood products and genetically modifying the target cells for clinical use in the field of cell and gene therapy. BACKGROUND

[0003] Gene-engineered autologous cell therapies, which utilize a patient’s own cells re- engineered and expanded ex vivo, represent a revolutionary approach to addressing complex diseases with high mortality and morbidity rates. These therapies leverage genetic modifications to correct underlying defects, offering transformative health outcomes for conditions where conventional treatments are limited or ineffective. Such gene-modified cell therapies, including those targeting hematopoietic cells such as T-cells, NK (Natural Killer) cells, and stem cells, have become a cornerstone of modern precision medicine, enabling targeted and durable interventions.

[0004] The field has witnessed rapid advancements, propelled by recent regulatory approvals and a robust development pipeline. Since 2017, multiple CAR-T cell therapies have received FDA approval for hematologic cancers, with over 1000 additional gene-modified therapies in U.S. clinical trials by late 2019. Beyond CAR-T therapies, CD34+ hematopoietic stem cells (HSCs) have shown similar promise for inherited disorders, including beta-thalassemia and severe combined immunodeficiency (SCID), with two therapies approved in the EU and over 31 pediatric trials underway in the U.S. as of 2019. Market forecasts predict a substantial expansion, with the global gene therapy market projected to grow from $18 billion in 2023 to over $97 billion by 2033. This growth reflects the increasing potential and demand for gene- modified cell therapies.

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Claims

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