Changhai Hospital cooperated with Zhangjiang Jikai gene to develop a breakthrough in the treatment of leukemia with CAR-T technology

Changhai Hospital cooperated with Zhangjiang Jikai gene to develop a breakthrough in the treatment of leukemia with CAR-T technology

November 04, 2016 Source: Wen Wei Po

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At the National Conference on Clinical Oncology held recently, Yang Jianmin, director of the Department of Hematology, Changhai Hospital, Second Military Medical University, told reporters an exciting news: in the Department of Hematology, Changhai Hospital, CAR-T technology in the clinical treatment of refractory acute lymphoblastic leukemia In the trial, 14 patients who had been treated were controlled to varying degrees. Among them, 12 patients with acute lymphoblastic leukemia achieved complete remission, and 2 patients with lymphoma had stable symptoms. So far, no patient died due to serious complications.
 
A little bit of the "fortress" of cancer
 
In the world of cancer treatment, immunotherapy is undoubtedly the most exciting development, allowing patients to use their own immune system to fight cancer cells in the body. CAR-T is a type of immunotherapy.
 
Simply put, CAR-T is a genetically engineered technology that artificially transforms T cells of tumor patients, and then grows in vitro to produce tumor-specific CAR-T cells, which are then returned to the patient to attack cancer cells.
 
Currently, CAR-T is mainly used for acute lymphoblastic leukemia. Yang Jianmin believes that in all medical specialties, the Department of Hematology is closer to basic medicine, and many major diseases are breakthroughs in the Department of Hematology. From the first time you get a tumor specimen, do a chemotherapy to see the effect, you can clearly know how the tumor changes, and a little bit of cancer "fortress".
 
The 14 patients in Changhai Hospital were selected to receive CAR-T cell immunotherapy when chemotherapy and stem cell transplantation could not be alleviated. "These patients are all free of charge." Yang Jianmin added.
 
The reason for free treatment is that the current domestic CAR-T therapy is limited to clinical research, and no clinical treatment has been approved. According to the reporter's understanding, some of the top three hospitals in Shanghai are also doing clinical research on CAR-T cancer treatment, and the attitude is generally cautious.
 
Scientific research advancement and commercial exploration encounter "double cold"
 
"Today, CAR-T, which continues to study one of the cellular immunotherapy technologies, is under great pressure," said Yang Jianmin.
 
Since May this year, domestic cellular immunotherapy has been cold, and medical institutions and enterprises involved in immunotherapy such as DC, CIK, DC-CIK have stopped research or sought transformation. The industry is more anxious, calling for not killing immunotherapy "a stick", so that the treatment that is truly effective for cancer can continue.
 
Internationally, CAR-T therapy, which represents a new direction in the industry, is attracting pharmaceutical companies to compete. For example, in 2014, the US Food and Drug Administration granted Novartis CAR-T immunotherapy CTL019 breakthrough therapy certification.
 
It is predicted that although the marketization of cellular immunotherapy represented by CAR-T is relatively backward, the market space in the future is still huge, and the market size will reach 10 billion yuan by 2020.
 
In China, many companies have cooperated with hospitals to carry out clinical research on CAR-T technology. They face two major problems: first, to further expand the clinical trial population, to verify the effectiveness and safety of this emerging heavy treatment technology in a larger sample; and second, how to take the path of commercial exploration.
 
The 14 cases of Changhai Hospital were promoted in cooperation with Shanghai Jikai Gene Technology Co., Ltd. In addition to co-developing CD19-CART treatment for “refractory relapsed leukemia”, they also jointly applied for the clinical application of CD123-CART cells in Shanghai. project.
 
Yang Jianmin said that the selection of Zhangjiang's Jikai gene as a partner is based on the fact that they have a set of quality control standards for the preparation of CAR-T cells, ensuring the safety of CAR-T cells used in clinical trials. But at the same time, he said that it is unreasonable to pay for it now--the doctor is scared and the company has no profit return. This is unscientific.
 
Yang Jianmin hopes that the relevant ministries and commissions will introduce hospitals and companies' access systems, including supervision and reasonable charging standards. "This way doctors know what they can do, and companies know what they can't do."
 
Industry self-discipline and interactive supervision
 
In the industry's view, after May of this year, immunotherapy suffered a setback, which is a concentrated outbreak of some problems in the domestic cellular immunotherapy industry. Its positive effect is to eliminate companies and institutions that only want to make money but are not qualified. At the same time, I would like to remind you that there are still many enterprises and hospitals participating in CAR-T clinical research. Now that they have full confidence in this new treatment technology, they need to establish a related research and application standard system.
 
It is understood that the National Health and Family Planning Commission is studying the management methods for clinical research of new medical technologies. The State Food and Drug Administration is also understanding the regulatory concepts of the US Food and Drug Administration on immunotherapy through various channels.
 
On September 19, 2016, the “Regulations on the Quality Management of Preparation of Immunocyte Preparations”, drafted by the China Pharmaceutical Biotechnology Association, began to solicit opinions. Yang Jianmin said, "The regulations are very strict from the draft. As a doctor, I also hope that the stricter and better the supervision, the kick-out of the enterprises that have been full of talents, and the growth of enterprises with technological advantages."
 
Yu Xuejun, general manager of Shanghai Jikai Gene Technology Co., Ltd. suggested that the State Food and Drug Administration and the National Health and Family Planning Commission may implement a filing system for the production of CAR lentiviral vector and implement GMP production management certification; the preparation process of CAR-T cells may be Refer to the implementation of the "Guidelines for Quality Control and Preclinical Research of Stem Cell Preparations" issued by the State; on the clinical research and future application of CAR-T cell therapy technology, it is recommended to follow the Health Planning Committee's "Restricted Clinical Application of Medical Technology (2015 Edition)" Provisions, declaration and approval.
 
"Can't stop, immunization is still a new technology that may overcome cancer. It requires enterprises to build technical thresholds and industry standards. Supervision may shift from 'one size fits all' regulation to 'interactive'." Yu Xuejun said.
 
Yang Jianmin also added that the public's understanding of attitudes is also critical in the face of any new medical technology. "Any medical technology is not omnipotent, including immunotherapy, which can only solve part of the problem. For a patient, it is like a straw. If it is caught, it may be cured, but it may sink." In his opinion, the doctor Patients and their families must have an objective and rational expectation based on the patient's actual situation.

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