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    Home > Biochemistry News > Biotechnology News > Cozi Bio-Targeted BCMA's CAR-T therapy is intended to incorporate breakthrough therapeutic varieties

    Cozi Bio-Targeted BCMA's CAR-T therapy is intended to incorporate breakthrough therapeutic varieties

    • Last Update: 2021-01-01
    • Source: Internet
    • Author: User
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    Screenshot Source: CDE official website CT053 is an innovative therapy developed by Kozi Bio, using human antibodies to target B cell mature antigen (BCMA) chime antigens (CAR) modified T cells, the main target adaptive disorder is R/R MM.
    BCMA is a member of the TNF-α super family, expressed mainly in mature B lymphocytes and plasma cells.
    of its greatest characteristics is expressed in all multiple myeloma cells and is an ideal antigen target for the treatment of MM.
    car-T therapy targeting BCMA targets MM cells by engineering the patient's T-cells in-body to express CAR specific to BCMA.
    The most obvious advantage is that modified CAR-T cells can amplification in the human body after a single infusion, which may give the body long-lasting immunity to cancer cells, meaning that patients are expected to achieve one-time drug treatment and "cure."
    BCMA CAR-T therapy (Photo Source: Supplied) After Cozi Bio published the results of CT053 clinical trials at several international conferences.
    Based on the follow-up results reported at the 17th International Symposium on Multiple Myeloma (IMW 2019), the total remission rate (ORR) of patients treated with CT053 relapse/difficult multiple myeloma was 87.5% and the total remission rate (CR/sCR) was 79.2%.
    , Kozi Bio announced that it will present the latest results of CT053's treatment of multiple myeloma at the 62nd Annual Meeting of the American Society of Hematology (ASH).
    includes the results of Phase 1 registered clinical trials in China, the results of 24-month follow-up to exploratory clinical trials in China, and the results of Phase 1b registered clinical trials in North America.
    The results of these three studies show that CT053 cells have consistent good tolerance in R/R MM patients in China and North America, significant and long-lasting clinical efficacy has been observed in patients treated with multiple lines, cell amplification is good in the body, and no anti-drug antibodies (ADA) have been detected.
    Screenshot Source: References. 1, China Phase 1 Registered Clinical Trials This study is a Phase 1 one-arm, open, multi-center registered clinical trial in China called Lummicar-1.
    the first public results of the study will be published on ASH, according to an earlier press release issued by Kozi Bio.
    as of July 20, 2020, the study recruited 14 subjects and received CT053 single cell infusions.
    subjects received at least three previous treatment options, including protease inhibitors (PI) and immunomodulation drugs (IMiD).
    14 R/R MM subjects, 3 received 1.0×108 cell infusions and 11 received 1.5×108 cell infusions.
    results showed good overall tolerance, no dose-limiting toxicity (DLT) was observed, no stage ≥ cytokine release syndrome (CRS) and CRS-related encephalopathy were detected, and no drug-resistant antibodies were detected.
    subjects received at least PR remission, ORR reached 100%, cells expanded well in the body, and CAR copies continued to be detected for up to 6 months.
    results show that CT053 with a target dose of 1.0-1.5×108 cell infusions can provide early and deep response to patients and has acceptable safety.
    this is basically consistent with the results of china's exploratory research and phase 1 clinical trials conducted in North America at the same time, and will support further critical Lummicar-1 research in China.
    2, China Phase 1 Exploratory Trials This is a one-arm, open-label Phase 1 clinical study initiated by researchers, and the results of the 24-month follow-up study will be presented in ASH.
    September 10, 2017 to September 22, 2018, a total of 24 adult R/R MM patients were admitted to the group and received CT053 cell infusions, who had previously received at least 2 rounds of myeloma treatment.
    as of June 30, 2020, the mid-level follow-up time of 24 subjects reached 17.9 months, or 89.5% for ORR, 79.2% for CR/sCR, and 9 subjects continued to be in CR/sCR, entering the long-term therapeutic follow-up phase.
    mPFS reached 18.8 months, with 6 and 12 months of PFS occurring at 87% and 60.9%, respectively.
    medium continuous remission (mDOR) was 21.8 months.
    Screenshot Source: Resources 2 These studies show that CT053 has excellent efficacy in R/R MM, showing early, deep and long-lasting reactions in 21.8 months of DOR.
    addition, CT053 was well-to-do in the subjects and ≥ level 3 CRS occurred.
    Phase 3, North America Phase 1b Registered Clinical Trials This is a one-arm, open, multi-center Phase 1b/2 study being conducted in North America called Lummicar-2.
    R/R MM subjects in the study had previously received at least 3 lines and more of therapy, including protease inhibitors, immunomodulation drugs, and anti-CD38 antibodies.
    July 28, 2020, 14 R/R MM received CT053 cell infusions, of which 8 received 1.5-1.8×108 cell infusions and 6 received 2.5-3.0×108 cell infusions.
    results showed good patient tolerance, no ≥3 CRS occurred, and 100% ORR was 100% for subjects who completed at least 8 weeks of efficacy follow-up in the first 10 cases.
    these results show that CT053 provides early and deeper responses to R/R MM patients with a target dose of 1.5-3.0×108 cell infusions and has acceptable safety.
    Lummicar-2 results are largely consistent with those of the two clinical trials conducted in China, which will support the launch of the critical Phase 2 Lummicar-2 study.
    overall, the results of these three studies were positive.
    , CT053 cells are expected to be a breakthrough product for the treatment of relapse/difficult MM, according to an earlier press release from Kozi Bio.
    MM is the second most common malignant tumor of the blood system after non-Hodgkin's lymphoma.
    despite significant advances in protease inhibitors, immunomodulation drugs and CD38 targeted antibodies in recent years, almost all patients eventually relapse.
    mm is considered an incurable disease with a five-year survival rate of about 50 percent and is expected to reach a global market share of $29 billion by 2027, according to a 2019 review published in The Reviews Drug Discovery.
    is clear that the urgent need for new drugs in this area is far from being met.
    Reference Center of the State Drug Administration of China. Retrieved Nov 30,2020, from # [2]Two-Year Follow-up of Investigator-Initiated Phase 1 Trials of the Safety and Efficacy of Fully Human Anti-Bcma CAR-T Cells (CT053) in Relapsed/Refractory Multiple Myeloma. Retrieved Nov 30,2020, from [3]Results from Lummicar-2: A Phase 1b/2 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Patients with Relapsed and/or Refractory Multiple Myeloma. Retrieved Nov 30,2020, from [4]Results from Lummicar-1: A Phase 1 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Chinese Subjects with Relapsed and/or Refractory Multiple Myeloma. Retrieved Nov 30, 2020, from the 2020 ASH Annual Meeting will present the latest findings of CT053 BCMA CAR-T cell therapy for multiple myeloma a. Retrieved Nov 19,2020, from [6]Shah, N., Chari, A., Scott, E. et al. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches. Leukemia 34, 985–1005 (2020). Source: Medical Mission Hills
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