Chimeric antigen receptor T-cell therapy (CAR T-cell therapy) is a promising form of cancer immunotherapy, it is the latest treatment option for several types of lymphoma, leukemia and multiple myeloma.
China has made significant contributions to the development of CAR T-cell therapy. By the end of 2023, four CAR T-cell therapies have been approved by the National Medical Product Administration (NMPA) of China for the treatment of lymphoma, leukemia and multiple myeloma, and over 400 clinical trials are undergoing across the country trying to find solutions for blood cancers and solid tumors.
Chinese researchers and medical institutions have been actively involved in CAR T-cell therapy research, clinical trials, and the development of new technologies.
In recent years, China has seen rapid progress in the field of CAR T-cell therapy, with several Chinese pharmaceutical companies and research institutions actively pursuing clinical trials and commercialization of CAR T-cell therapies. The country has also made notable advancements in the development of novel CAR T-cell constructs, manufacturing processes, and treatment protocols.
Furthermore, China’s large patient population and growing healthcare infrastructure have provided valuable opportunities for conducting clinical trials and gathering real-world evidence on the efficacy and safety of CAR T-cell therapies. This has contributed to a better understanding of the therapy’s potential and limitations.
Overall, China’s input in the development of CAR T-cell therapy has been substantial, and its contributions are expected to continue shaping the future of this innovative cancer treatment approach.
T cells are collected from a patient. T cells are collected via apheresis, a process that withdraws blood from the body and removes one or more blood components (such as plasma, platelets or white blood cells). The remaining blood is then returned back into the body. T cells are reengineered in a laboratory. The T cells are sent to a laboratory or a drug manufacturing facility where they are genetically engineered to produce chimeric antigen receptors (CARs) on their surface. After this reengineering, the T cells are known as “chimeric antigen receptor (CAR) T cells.” CARs are proteins that allow the T cells to recognize an antigen on targeted tumor cells. The reengineered CAR T cells are then multiplied. The number of the patient’s genetically modified T cells is “expanded” by growing cells in the laboratory until there are many millions of them. These CAR T cells are frozen and, when there are enough of them, they are sent to the hospital or center where the patient is being treated. At the hospital or treatment center, the CAR T cells are then infused into the patient. Many patients are given a brief course of one or more chemotherapy agents before they receive the infusion of CAR T cells. CAR T cells that have been returned to the patient’s bloodstream multiply in number. These are the “attacker” cells that will recognize, and kill, cancerous cells that have the targeted antigen on their surface. The CAR T cells guard against recurrence. CAR T cells may remain in the body long after the infusion has been completed. They guard against cancer recurrence, so the therapy frequently results in long-term remissions. At this time, CAR T-cell therapy is only available to patients who are participating in a clinical trial. Trial protocols vary. Depending on the clinical trial, care may be provided in either a hospital setting or a treatment center. Patients may have to stay at the treatment facility, or they may need to plan to stay close by before, during or following treatment. Some trial protocols require patients to confirm the availability of a caregiver before they can enroll in the trial..
Cytokine-Release Syndrome (CRS). A serious side effect associated with CAR T-cell therapy is cytokine-release syndrome (CRS). CRS is the result of T-cell activation, so its presence actually indicates a positive response to therapy. Cytokines are chemical messengers that help the T cells perform their duties. With CAR T-cell therapy, large amounts of cytokines are produced by the activated immune system. CRS in this setting may cause high fevers, low blood pressure or poor lung oxygenation (requiring administration of supplemental oxygen as a temporary measure). Some patients experience delirium, confusion and seizure while undergoing treatment. The onset of these symptoms is typically within the first week of treatment. These symptoms, however, are reversible. B-Cell Aplasia. CAR T-cell therapy targeting antigens found on the surface of B cells not only destroys cancerous B cells but also normal B cells. Therefore, B cell aplasia (low numbers of B cells or absent B cells) is an expected side effect. This absence of B cells results in less ability to make the antibodies that protect against infection. Intravenous immunoglobulin replacement is used to prevent infection. It is not known how long the decreased number of B cells persists however, no long-term side effects have been noted. Tumor Lysis Syndrome (TLS). Another known side effect of CAR T-cell therapy is tumor lysis syndrome (TLS), a group of metabolic complications that can occur due to the breakdown of dying cells—usually at the onset of toxic cancer treatments. However, TLS can occur one month or more after CAR T-cell therapy. TLS can be a life-threatening complication of any treatment that causes breakdown of cancer cells, including CAR T cells. The complication has been managed by standard supportive therapy.
Early results from CAR T-cell trials have generated impressive results and considerable promise in patients with blood cancers. Acute lymphoblastic leukemia (ALL). CAR T-cell therapy may represent options for ALL patients who have relapsed after intensive chemotherapy or a stem cell transplant. In some studies, up to 90 percent of children and adults with ALL who had either relapsed multiple times, or failed to respond to standard therapies, achieved remission after receiving CAR T-cell therapy. Other blood cancers. Studies of CAR T-cell therapy in other blood cancers, including chronic lymphocytic leukemia (CLL), some types of non-Hodgkin lymphoma (NHL) including diffuse large B cell lymphoma (DLBCL) and follicular lymphoma, as well as multiple myeloma, are also very promising. While data is fast emerging as to the early responses to CAR T-cell therapy, most of the patients participating in these clinical trials have only been followed for a relatively short period of time. Following these trial participants over the long term will provide information as to the length of their responses. It is important for more pediatric and adult patients to be enrolled in clinical trials. Larger study samples, looked at over more extended periods, will help researchers further understand the impact of this type of therapy, ways to reduce its toxicity and also improve toxicity management.
Talk with your doctor about whether participation in a CAR T-cell therapy clinical trial is an option for you. Obtaining another opinion from a hematologist–oncologist (a blood cancer specialist), may be helpful in finding additional clinical-trial information as well. When you discuss CAR T-cell therapy as a potential treatment option for you, it may be helpful to have
In addition to speaking with your doctor, LLS Information Specialists, available at (800) 955-4572, offer guidance on how patients can work with their doctors to determine if a specific clinical trial is an appropriate treatment option. Information Specialists can search for clinical trials on behalf of patients, family members and healthcare professionals.
China has seen rapid growth in its biotech industry, particularly in the area of CAR T-cell therapy. Many Chinese biotech firms have developed their own CAR T-cell therapies and are actively seeking partnerships with international pharmaceutical companies. As the second-largest country in terms of the number of CAR T-cell therapy clinical trials, China’s research efforts reflect its commitment to advancing this innovative treatment approach.
Moreover, China has implemented various measures to make CAR T-cell therapy more accessible and affordable for patients. These patient-friendly pricing strategies have indeed contributed to making China an attractive destination for international patients for innovative therapies like CAR T-cell therapy. Comparatively, the cost of CAR T-cell therapy in China may be relatively more affordable than in other countries.
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