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The FDA has awarded Calibr the new "switchable" CAR-T cell therapy CLBR001 and SWI019 "fast track title" to accelerate drug development and review.
, the therapy is being evaluated as a treatment for B-cell malignancies, including non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
CAR-T cell therapy CLBR001 and SWI019 have begun recruiting subjects to Phase I clinical trials to assess the safety and toerability of the cell therapy, which is being conducted in several locations in the United States.
Pamela Garzone, chief medical officer of Calibr, said: "The fast track designation will enable Calibr to interact with the FDA in related research, such as appropriate data collection and research design, to support the approval of this innovative therapy."
Calibr's research CAR-T cell therapy uses the patient's own immune cells to treat cancer, keeping them under the control of a new molecular "switch" that seeks to mitigate the so far potentially life-threatening side effects that have hampered the use of cell therapy.
Calibr's "switchable" CAR-T cell therapy combines an antibody called SWI019, which can act as a "switch" to activate engineered cells (CLBR001) and guide them to bind to cancer targets.
this gives doctors more control over treatment, providing a clear safety advantage.
in preclinical studies, this method has been shown to be very effective in eliminating tumors while controlling cytokines resulting from treatment.
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