☆ 4.6 Review

Systematic Review on CAR-T Cell Clinical Trials Up to 2022: Academic Center Input

CANCERS (2023)

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Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

Maja Pizevska et al.

Summary: Advanced Therapy Medicinal Products (ATMPs) such as cell, gene, and tissue-engineered therapies offer significant therapeutic benefits. However, managing their development within existing regulatory frameworks is complex. Legislation and regulation for ATMPs should prioritize patient safety while promoting innovation and optimizing the development of these novel therapies. Ongoing dynamic dialogue between stakeholders and regulatory science is crucial to facilitate the establishment of practical ATMP regulatory guidelines.

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Toward Rapid, Widely Available Autologous CAR-T Cell Therapy - Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital

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Summary: CAR-T cell therapy has shown promise in treating acute leukemia and lymphoma, but its widespread use is limited due to high manufacturing costs and low clinical success rates. To address these challenges, an AI-driven automated CAR-T cell manufacturing platform is being developed to improve efficiency and cost-effectiveness through automation and data analysis.

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Gene and cell therapies in China: booming landscape under dual-track regulation

Chen Yin et al.

Summary: The booming of gene and cell therapy, especially in the field of cancers, has been observed worldwide. By analyzing clinical trials in China, it was found that CAR-T therapies from the ex vivo category and stem and somatic cells from the non-gene category were the most studied therapy types. The number of investigator-initiated trials exceeded IND-registered trials, and all categories experienced rapid growth after 2017.

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Potential solutions for manufacture of CAR T cells in cancer immunotherapy

Ulrich Blache et al.

Summary: CAR T cell therapy is effective in treating cancer, but obstacles in biology and manufacturing hinder its widespread application. New technologies are needed to enable the treatment of larger patient groups.

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Valentin Ortiz-Maldonado et al.

Summary: Evaluation of ARI-0001 cell administration in patients with relapsed/refractory CD19(+) malignancies showed significant efficacy in ALL patients, with low rates of neurotoxicity and procedure-related mortality.

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Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States

Carolina Iglesias-Lopez et al.

Summary: Regulatory agencies in the European Union (EU) and in the United States of America (USA) have adapted and launched regulatory pathways to accelerate patient access to innovative therapies, such as advanced therapy medicinal products (ATMPs). The main regulatory milestones reached by the approved ATMPs are similar in both regions, with the exception of the time for MAA evaluation, the number of authorized products in the regions, and the type of authorization for some products.

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CARAMBA: a first-in-human clinical trial with SLAMF7 CAR-T cells prepared by virus-free Sleeping Beauty gene transfer to treat multiple myeloma

Sabrina Prommersberger et al.

Summary: Clinical development of CAR-T-cell therapy has been advanced by synthetic biology, genetic engineering, and clinical-grade manufacturing, with the goal of providing safe, effective, and economically sustainable treatment. The CARAMBA project aims to demonstrate virus-free CAR gene transfer using advanced SB transposon technology, potentially improving vector procurement, CAR-T manufacturing, and distribution. The project focuses on utilizing SB-based CAR-T cells targeting the SLAMF7 antigen in multiple myeloma, with promising preclinical results indicating potent anti-myeloma activity.

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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

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BMJ-BRITISH MEDICAL JOURNAL (2021)

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Production and Application of CAR T Cells: Current and Future Role of Europe

Vladan Vucinic et al.

Summary: The rapid developments in CAR T cell therapy present both opportunities and challenges. Europe plays a significant role in this field. Advancements in manufacturing techniques, from manual to automated processes, are expected to lower costs and complexity in producing CAR T cell products for a greater number of patients and a variety of diseases.

FRONTIERS IN MEDICINE (2021)

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Review Oncology

Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy

Mohamed Abou-el-Enein et al.

Summary: This review discusses the current status of commercially available CAR T cell therapies for hematologic malignancies and the shift towards Good Manufacturing Practice-compliant closed and automated systems in the industry. It also highlights the emerging technologic advances in CART cell manufacturing and the challenges in scaling production for clinical use. The review emphasizes the significance of closed and automated production platforms to meet the increasing demand for CAR T cell cancer therapy.

BLOOD CANCER DISCOVERY (2021)

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Review Oncology

Requirements for academic production of CAR-T cells in accordance with Good Pharmaceutical Practice (GMP). Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)

Marina Deschamps et al.

BULLETIN DU CANCER (2020)

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Review Cell & Tissue Engineering

The long road to the first FDA-approved gene therapy: chimeric antigen receptor T cells targeting CD19

Peter Braendstrup et al.

CYTOTHERAPY (2020)

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Article Oncology

Head-to-head comparison of in-house produced CD19 CAR-T cell in ALL and NHL patients

Orit Itzhaki et al.

JOURNAL FOR IMMUNOTHERAPY OF CANCER (2020)

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Transposon-Based CAR T Cells in Acute Leukemias: Where Are We Going?

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CELLS (2020)

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Demonstrating the Manufacture of Human CAR-T Cells in an Automated Stirred-Tank Bioreactor

Elena Costariol et al.

BIOTECHNOLOGY JOURNAL (2020)

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Cost of decentralizedCART-cell production in an academic nonprofit setting

Tao Ran et al.

INTERNATIONAL JOURNAL OF CANCER (2020)

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Improvement of in vitro potency assays by a resting step for clinical-grade chimeric antigen receptor engineered T cells

Lei Wang et al.

CYTOTHERAPY (2019)

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Article Medicine, Research & Experimental

Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions

Maria Castella et al.

MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT (2019)

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Article Hematology

GMP CAR-T cell production

Adrian P. Gee

BEST PRACTICE & RESEARCH CLINICAL HAEMATOLOGY (2018)

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Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia

S. L. Maude et al.

NEW ENGLAND JOURNAL OF MEDICINE (2018)

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Article Hematology

Locally produced CD19 CAR T cells leading to clinical remissions in medullary and extramedullary relapsed acute lymphoblastic leukemia

Elad Jacoby et al.

AMERICAN JOURNAL OF HEMATOLOGY (2018)

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Review Medicine, General & Internal

Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges

Rohin K. Iyer et al.

FRONTIERS IN MEDICINE (2018)

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Article Biotechnology & Applied Microbiology

Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma

Frederick L. Locke et al.

MOLECULAR THERAPY (2017)

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Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma

S. S. Neelapu et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

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Global Manufacturing of CAR T Cell Therapy

Bruce L. Levine et al.

MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT (2017)

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Prerequisite for hematopoietic cellular therapy programs to set up chimeric antigen receptor T-cell therapy (CAR T-cells): Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)

Ibrahim Yakoub-Agha et al.

BULLETIN DU CANCER (2017)

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Review Medicine, Research & Experimental

Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts

Jessica Hartmann et al.

EMBO MOLECULAR MEDICINE (2017)

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Article Cell & Tissue Engineering

Automated manufacturing of chimeric antigen receptor T cells for adoptive immunotherapy using CliniMACS Prodigy

Ulrike Mock et al.

CYTOTHERAPY (2016)

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Review Oncology

Toxicity and management in CAR T-cell therapy

Challice L. Bonifant et al.

MOLECULAR THERAPY-ONCOLYTICS (2016)

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Review Biotechnology & Applied Microbiology

Manufacture of T cells using the Sleeping Beauty system to enforce expression of a CD19-specific chimeric antigen receptor

H. Singh et al.

CANCER GENE THERAPY (2015)

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Review Biotechnology & Applied Microbiology

TRUCKs: the fourth generation of CARs

Markus Chmielewski et al.

EXPERT OPINION ON BIOLOGICAL THERAPY (2015)

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Article Hematology

Closely related T-memory stem cells correlate with in vivo expansion of CAR.CD19-T cells and are preserved by IL-7 and IL-15

Yang Xu et al.

BLOOD (2014)

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Review Immunology

Design and development of therapies using chimeric antigen receptor-expressing T cells

Gianpietro Dotti et al.

IMMUNOLOGICAL REVIEWS (2014)

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Article Biotechnology & Applied Microbiology

Chimeric Receptors Containing CD137 Signal Transduction Domains Mediate Enhanced Survival of T Cells and Increased Antileukemic Efficacy In Vivo

Michael C. Milone et al.

MOLECULAR THERAPY (2009)

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Article Hematology

Single-chain antigen recognition receptors that costimulate potent rejection of established experimental tumors

NM Haynes et al.

BLOOD (2002)

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