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HRAIN01 is an autologous chimeric antigen receptor (CAR) T-cell therapy developed by Hrain Biotechnology. It consists of a patient's own T cells that have been genetically engineered to express a CAR specific for the CD19 antigen, a protein highly expressed on the surface of B-cell lineage cells. Upon re-infusion into the patient following lymphodepleting chemotherapy (typically fludarabine and cyclophosphamide), these CAR-T cells recognize and bind to CD19-positive malignant cells, leading to T-cell activation, proliferation, and the subsequent destruction of the target cells. HRAIN01 is primarily being investigated in Phase I clinical trials for the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
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