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About CNCT19 (CD19 chimeric antigen receptor (CAR) modified T cells)

CID-103 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 the 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), the Chinese National Health Authority. Enrollment to these studies was closed in June 2018.

The China National Medical Product Administration (NMPA) has approved the clinical trial applications for CNCT19 in B-ALL and B-NHL. The Phase 2 B-NHL and B-ALL registration studies of CNCT19 are currently enrolling in China. Breakthrough designation received for B-ALL.

CASI intends for CNCT (CD19 CAR-T) to be locally developed and manufactured so that it can be more affordable and widely accessible to patients.

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.

About Non-Hodgkin lymphoma

Non-Hodgkin lymphoma (NHL) is an umbrella term for a group of cancers that develop in the body’s lymphatic system. Examples of sub-indications are patients with Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL). Examples of sub indications are patients with Mantle Cell Lymphoma, Follicular Lymphoma, and Marginal Zone Lymphoma.

About Us

CASI is a U.S. NASDAQ-listed biopharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China, through which substantially all of our operations are conducted.

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