CAR T-cell therapy has shown the disappearance of leukemia

in clinical practice

Professor Kang Hyung-jin's team at Seoul National University Hospital confirms research on advanced regenerative medicine

The MOHW strengthens support for education, R&D, and GMP to derive quality results

A research team of domestic CAR-T (Chimeric Antigen Receiver-T Cell) treatment confirmed the disappearance of leukemia cells in clinical trials of pediatric and adolescent leukemia patients.

 

The government plans to positively evaluate the treatment of children and adolescents with leukemia through advanced regenerative medical clinical research and continue to provide related policy support.

 

The MOHW (Minister Kwon Deok-cheol) announced on the 7th that the results of the disappearance of leukemia cells in children and adolescents through advanced regenerative medical clinical research research at Seoul National University Hospital (Director Kang Hyung-jin).

 

CAR-T introduces a gene that combines the receptor site of an immune cell (T cell) and the characteristic antigen recognition site on the surface of a cancer cell into a patient's T cell and is a cell with a function of specifically recognizing and attacking the surface antigen of a cancer cell.

 

This study is a high-risk clinical study, which was approved and approved as the first high-risk clinical study by the Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee and the MFDS in December.

 

Seoul National University Hospital said it administered its own CAR-T treatment to an 18-year-old leukemia patient on February 28, and that a bone marrow test conducted on March 28 confirmed that leukemia cells completely disappeared.

 

This project is to support research funds for clinical studies approved or approved by the Council and the MFDS.

 

In addition to this clinical study at Seoul National University Hospital, it is also supporting clinical research conducted by Samsung Medical Center and Catholic University Industry-Academic Cooperation.

 

Seoul National University Hospital receives 1.25 billion won in research funds from 2022 to 2023, Samsung Medical Center 1.83 billion won from March 2022 to December 2023, and Catholic University Industry-Academic Cooperation Group 1 billion won from 2022 to 2023.

 

As of the end of March, a total of five clinical studies were finalized and approved by the Deliberation Committee and the MFDS, and one high-risk clinical study and one medium-risk clinical study will also apply for research funding to the Advanced Regenerative Clinical Research Support Group.

 

The MOHW explained that the number of applications and applications for advanced regenerative medical clinical research has been on the rise since the Advanced Regenerative Bio Act took effect in August 2020 and the deliberation committee began to form and operate in January 2021.

 

The deliberation committee is determining whether or not to make a decision on the suitability of clinical research in consideration of the validity and safety of the research plan, and the proportion of clinical research that has recently been approved is increasing.

 

Among them, the number of suitable resolutions through the deliberation committee so far has been 10.

 

Recently, the advanced regenerative medical field is attracting attention as a future food in the biohealth field, and as the number of advanced regenerative medical institutions capable of conducting clinical research continues to increase, advanced regenerative medical research is expected to be further activated.

 

Accordingly, the government will strengthen legal essential education for clinical research personnel, R&D for virus production and human transplantation, and GMP support to promote joint research between hospitals and startups.

 

"It is encouraging to provide treatment opportunities for pediatric leukemia patients through the first high-risk clinical study," said Kim Young-hak, head of the MOHW.

 

"We will do our best to provide treatment opportunities to more patients through pan-ministerial regenerative medical technology development projects."