17 June 2019
About CNCT19 (CD19 chimeric antigen receptor (CAR) modified T cells)
CNCT19 is a chimeric antigen receptor (CAR) modified T cell (CAR-T). The CD19 antigen is a frequently used target in CAR-T cell therapy for certain hematological malignancies such as certain leukemias and lymphomas.
The active therapeutic modality of CNCT19 are T-cells which have been genetically modified to express chimeric antigen receptors (CARs) targeting CD19. These CAR-T cells are prepared from the individual patient’s own peripheral blood CD3 positive cells. After genetic modification and expansion, the CNCT19 cells are resuspended in a specialized solution containing no preservatives or antibodies and re-infused into the patient. The CNCT19 cells can recognize the CD19 molecules on the surface of patient’s cancer cells and will actively seek out and kill these CD19 positive cancer cells.
Clinical Development Status
The technology which enabled the production of CNCT19 has previously been invested in clinical studies sponsored by academic investigators at the Institute of Hematology and Blood Diseases Hospital, Tianjin, China. These initial studies evaluated the safety and efficacy of the treatment in patients with CD19-positive relapsed/refractory acute lymphoblastic leukemia (ALL) and CD19-positive relapsed/refractory invasive B-cell non-Hodgkin’s lymphoma.
The study objectives included assessment of the safety and efficacy of the CD19 CART-cell therapy. The studies were approved by the institutional review board at the study site and were conducted in accordance with the Good Clinical Practice guidelines of the National Medical Products Administration (NMPA [Chinese National Health Authority]). Enrollment to these studies was closed in June 2018. The CNCT19 Clinical Trial Application is currently under review by the NMPA.
About Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)
Relapsed and refractory acute lymphoblastic leukemia (ALL) are difficult to treat diseases. In the case of relapsed leukemia, some patients have a return of ALL cells in the marrow and a decrease in normal blood cells after remission. This is referred to as relapse. In some patients with ALL, the anti-cancer treatments may not completely eliminate the leukemia cells in the bone marrow, this is called refractory leukemia.
Complete remission (CR) rates have been reported in both children and adults with relapsed and refractory ALL who have been treated with CAR-modified T cells targeting the B-cell-specific antigen CD19.