In the non-oncology field, the first domestic IND for CAR-T treatment of autoimmune diseases was accepted

On May 28, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of the People's Republic of China announced that Reindeer Bio had submitted two clinical trial applications for Iquirenza injection, which were accept.

CT103A was jointly developed by Reindeer Bio and Innovent Bio, and used lentivirus as a gene carrier to transfect autologous T cel.

This time, the clinical trial application submitted by CT103A is for a new indication, neuromyelitis optica spectrum disorder (NMOS.

The application for the new indication of CT103A is based on an investigator-initiated clinical study (IIT), and the subjects enrolled in the study are refractory optic nerve patients who have been treated with at least one immunosuppressant for more than one year, but whose symptoms are not well controlled patients with myelitis spectrum disorde.

The research data preliminarily showed that the 5×10^6 CAR-T cells/kg and 0×10^6 CAR-T cells/kg dose groups of Iquilenxe injection demonstrated in the treatment of NMOSD subjects poorly controlled by conventional therapy In order to ensure a relatively reliable safety, all CRS (cytokine release syndrome) were grade 1-2, and no ICANS (immune effector cell-associated nervous system syndrome) was observ.

In addition to CT103A, Reindeer Bio has more than 10 varieties under development at different stages of development, and its self-developed innovative product CT120 (full human CD19/CD22 dual-target CAR-T cell injection) has entered the clinical research sta.