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    Home > Active Ingredient News > Antitumor Therapy > Genxi Bio announced the completion of the first patient enrollment in the Phase I/II registered clinical study of donor-derived allogeneic CAR-T cell therapy GC007g for relapsed/refractory B-ALL

    Genxi Bio announced the completion of the first patient enrollment in the Phase I/II registered clinical study of donor-derived allogeneic CAR-T cell therapy GC007g for relapsed/refractory B-ALL

    • Last Update: 2021-04-14
    • Source: Internet
    • Author: User
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    Recent popular reports from Yimaike ★ GC019F CAR-T developed by Genxi Bio based on the FasTCAR platform for adult patients with relapsed or refractory B-ALL was approved by the IND to enter the registered clinical study★ Genxi Bio GC007g is the first donor-sourced allogeneic gene in China CAR-T cell therapy is approved to enter Phase I/II registration clinical study April 2, 2021/MedClub News/--Suzhou and Shanghai, China-- Committed to the development of efficient and economical cell therapy for cancer treatment worldwide The clinical stage biopharmaceutical company Genxi Biotechnology Group (NASDAQ: GRCL; referred to as "Genxi Bio") announced that it is used for the treatment of acute B-cell lymphocytic leukemia (B-ALL).
    CD19 Chimeric Antigen Receptor (CAR)-T cell therapy GC007g phase I/II registration clinical study completed the first patient enrollment.

     GC007g is a donor-derived allogeneic CAR-T cell therapy that uses human leukocyte antigen (HLA) matched donor T cells.

    Previously, China's National Medical Products Administration had approved Genxi Biologics to carry out a new drug clinical trial application (IND) for the treatment of B-ALL with GC007g, and in December 2020, it again approved Genxi Biologics to carry out Phase I/II registered clinical studies.

    This open, single-arm Phase I/II registration study aims to evaluate the safety and effectiveness of GC007g in the treatment of patients with relapsed/refractory B-ALL.

    "We are pleased to announce that the registered phase I/II trial of the CAR-T therapy GC007g targeting CD19, which is used to treat B-ALL patients with donor-derived allogeneic genes, successfully recruited the first patient into the group," Genxi Bio Chief Medical Officer Dr.
    Martina Sersch said, “GC007g is a unique treatment for B-ALL patients who have relapsed after allogeneic stem cell transplantation and do not meet the standard treatment conditions.

    Genxi Bio has an innovative product portfolio under development, and we look forward to continuously bringing more breakthrough CAR-T therapies to patients to solve more clinical unmet needs.

    "The principal investigator of the GC007g clinical study, Professor Zhang Xi from the Hematology Medical Center of Chongqing Xinqiao Hospital (the Second Affiliated Hospital of the Army Military Medical University) said: "In terms of the current clinical situation, B- who has relapsed after receiving allotransplantation in the past Patients with ALL may not be able to receive autologous CAR-T cell therapy due to poor health and activity of their own cells, or due to infection and other conditions.

    Genxi Bio's unique GC007g donor-derived allogeneic CAR-T cell therapy will bring new treatment options to these patients and is expected to allow them to achieve disease remission again.

    I very much look forward to the positive progress of this research and benefit more patients as soon as possible.

    "At present, the team of Professors Zhang Xi and Gao Lei of Chongqing Xinqiao Hospital has successfully enrolled the first subject; the clinical trial is also being carried out simultaneously in the First Affiliated Hospital of Zhejiang University School of Medicine, under the responsibility of a team led by Professor Huang He.

     About GC007gGC007g It is a donor-derived CAR-T cell therapy targeting CD19.

    This candidate product has completed a phase I trial initiated by the investigator in China for the treatment of relapsed/refractory B-ALL.

    CAR-T cells in this therapy are prepared based on human leukocyte antigen (HLA) matched healthy donor T cells.

     About B-ALL B-ALL is a major form of acute lymphoblastic leukemia (ALL), which is 2-5 One of the most common forms of cancer in children aged 50 years and older [1].

    In 2015, approximately 837,000 people worldwide had ALL, resulting in approximately 110,000 deaths [2].

    This cancer is also the most common form in children Types of carcinogenesis and causes of death.

     About Genxi Biotech Genxi Biotechnology Group (referred to as "Genxi Bio") is a global clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies.

    Using its pioneering FasTCAR and TruUCAR technology platforms, Genxi Bio is developing a rich clinical stage product pipeline that includes a variety of autologous and allogeneic candidate products.

    These products are expected to overcome the major industry challenges that continue to exist in traditional CAR-T therapy, including long production time, poor production quality, high treatment costs, and the lack of effective CAR-T therapy for solid tumors.

     Cautionary Statement Regarding Forward-Looking Statements The statements in this press release regarding future expectations, plans, prospects, and other non-historical facts may include those defined under the Private Securities Litigation Reform Act of 1995 "Forward-looking Statement".

    These statements include, but are not limited to, statements related to the expected transaction and completion time of this issuance.

    These statements may but not necessarily contain the following vocabulary and the corresponding negative or similar vocabulary: purpose, expectation, belief, estimation, prediction, prediction, plan, possibility, prospect, plan, potential, speculation, drafting, seeking, possible , Should, will.

    Due to various important factors, actual results may differ materially from forward-looking statements, and there is no guarantee that any forward-looking statements will be realized.

    These important factors include market conditions, the uncertainty of completing the public offering based on forecast terms, and other risk factors mentioned in the "Risk Factors" section of the final prospectus submitted to the US Securities Regulatory Commission.

    Any forward-looking statements in this statement only reflect current expectations, and Genxi Biotech is not responsible for publicly updating or reviewing any forward-looking statements, whether based on new information, future events or other reasons.

    Readers are requested not to rely on forward-looking statements after the publication date of this press release.

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