Gracell Announces First-in-Human Clinical Trial of Its Dual-Target FasTCAR-T Cell Therapy GC012F for B-Cell Non-Hodgkin Lymphoma Completes First Patient Dosing

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ROOTO, recently, Gracell Biotechnology Group (NASDAQ: GRCL; referred to as "Gracell" or the "Company"), a global clinical-stage company dedicated to the development of highly effective and cost-effective cell therapies for cancer treatment The biopharmaceutical company announced today that it has launched a new clinical trial evaluating the company's core candidate BCMA/CD19 dual-target autologous CAR-T cell therapy GC012F for the treatment of B-cell non-Hodgkin's lymphoma (B-NHL).
Complete multiple patient dosing
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Currently, non-Hodgkin lymphoma is the fifth most common cancer in the United States1 and one of the most common hematological malignancies in China
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This investigator-initiated Phase I clinical trial (IIT) in China is an evaluation of the safety of GC012F in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).
and first-in-human clinical trials of efficacy
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As a result, GC012F has become the first BCMA/CD19 dual-target CAR-T cell therapy to carry out relevant human clinical studies for B-NHL indications
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It is currently known clinically that the vast majority of B-NHL tumor cells express CD19; in addition, research data also show that 39%-97% of clinical samples of B-NHL tumor cells also express BCMA234
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Therefore, by targeting both BCMA and CD19 targets simultaneously, GC012F is expected to further provide better efficacy for r/r B-NHL patients
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GC012F is a product candidate based on Gracell's proprietary FasTCAR platform technology, with the advantage of "next day production"; the therapy is currently in multiple Phase I clinical trials initiated by clinical investigators in China (IIT), including previously disclosed clinical studies in relapsed/refractory multiple myeloma
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In November 2021, the US FDA has granted GC012F orphan drug designation
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"Gracil pioneered the application of BCMA/CD19 dual-target CAR-T cell therapy in the field of B-NHL treatment, and further explored the broader clinical value of GC012F
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This time, the clinical study of GC012F on r/r B-NHL The successful completion of the first batch of patient dosing also marks a key step for Gracell to further expand the indications of its core products
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" Dr.
Martina Sersch, Chief Medical Officer of Gracell, said: "In the future, with further research , we are very much looking forward to showing the potential of GC012F in the treatment of B-NHL as soon as possible, and providing a new treatment option for patients who are eagerly looking forward to it.
The core product GC012F, the company's self-created FasTCAR platform and dual-target design
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" About GC012FGC012F is a dual-targeted autologous CAR-T therapy candidate product developed based on the FasTCAR platform
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Currently, the product candidate is evaluating its safety and efficacy in multiple myeloma and B-cell non-Hodgkin lymphomas in multiple investigator-initiated, multicenter, Phase I clinical trials in China
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By targeting BCMA and CD19 at the same time, GC012F can bring rapid, in-depth and lasting therapeutic effects, helping patients with multiple myeloma and B-cell non-Hodgkin lymphoma to improve the treatment response rate and reduce the recurrence rate
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About B-cell non-Hodgkin's lymphoma (B-NHL) Non-Hodgkin's lymphoma (NHL) is a class of hematological malignancies that originate in lymph nodes and other lymphoid tissues, commonly found in B-cells (B-NHL)
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About 510,000 patients worldwide are diagnosed with NHL every year; in 2020, more than 77,000 and 68,000 patients are expected to be diagnosed with NHL in the United States and China, respectively, of which B-NHL patients account for about 85% of the total NHL patients
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About FasTCAR FasTCAR is Gracell's intellectual property technology platform for the development of high-quality autologous CAR-T cell therapy
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Preclinical studies have shown that CAR-T cells produced through the FasTCAR technology platform have a younger phenotype, less exhaustion, and enhanced expansion capacity, persistence, bone marrow migration capacity, and tumor cell clearance activity
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With the advantage of "next-day production", the FasTCAR platform technology can greatly improve the efficiency of cell production, thereby significantly reducing production costs and enabling cell therapy to benefit more cancer patients
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About Gracell Gracell Biotechnology Group ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies
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Leveraging its groundbreaking three breakthrough technology platforms, FasTCAR, TruUCAR and SMART CARTTM, Gracell is developing a rich pipeline of autologous and allogeneic clinical-stage cancer therapeutics
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These products are expected to overcome significant industry challenges that persist with traditional CAR-T therapies, including long production times, poor production quality, high treatment costs and lack of effective treatment for solid tumors
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To learn more about Gracell, visit and follow @GracellBio on LinkedIn
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References: 1.
https:// Blood Cancer Journal (2020) 10:733.
Blood.
2017;130:2755.
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Hum Gene Ther.
2018 ; 29(5): 585.
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