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    Home > Active Ingredient News > Drugs Articles > FDA approved cellectis general car-t therapy clinical trial to continue

    FDA approved cellectis general car-t therapy clinical trial to continue

    • Last Update: 2017-11-20
    • Source: Internet
    • Author: User
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    Source: biovale 2017-11-20 recently, cellectis announced that FDA allows the clinical trials of its product under development, car-t cell variant ucart123, to continue Ucart123 is carrying out clinical trials in the treatment of acute myeloid leukemia (AML) and maternal plasma cell like dendritic cell tumor (bpdcn) Ucart123 is a "universal" car-t therapy Different from traditional car-t therapy, ucart123 needs to transform patients' own T cells Allogeneic T cells can be prepared in advance and provided to patients at any time regardless of the quality of their own T cells Ucart123 has been transformed into T cells that can target CD123 antigen which is widely expressed on the surface of acute myeloid leukemia and bpdcn cancer cells In February this year, it became the first universal car-t therapy approved by FDA to enter clinical trials However, in the course of the trial, a patient died, which led the FDA to suspend the trial on September 4, requiring cellectis to redesign ucart123 in terms of safety After discussion with FDA, cellectis decided to make a series of changes to the clinical phase 1 trial of ucart123 Cellectis is currently working with investigators and clinical websites to obtain IRB approval for the revised protocol and to restore patient registration This year is the first year of car-t therapy At present, there are two car-t therapies on the market If the universal car-t therapy can come out smoothly, there is a new treatment plan for patients Hope that the test of universal car-t therapy can be carried out successfully and bring hope to patients!
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