An innovative immunotherapy called CAR T-cell treatment has seen substantial growth in China’s medical community. CAR T Cell therapy in China is progressing remarkably and has the potential to revolutionize cancer treatment. China is now a pioneer in this industry thanks to its strong regulatory framework and research infrastructure, which have fueled its development. CAR T-cell treatments have been successfully developed by a number of Chinese biopharmaceutical companies, showing encouraging results for patients with hematologic malignancies. Furthermore, China’s enormous patient population offers a special benefit for carrying out clinical trials and compiling data. China’s efforts are influencing the future of precision medicine and providing fresh hope for cancer patients all across the world as CAR T-cell treatment advances.
August 2023: Cancer patients who previously had few options now have hope because to CAR-T cell therapy, which has revolutionized the area of cancer treatment. With several clinical trials being conducted to increase the efficacy and safety of CAR-T cell therapy, China has emerged as a leader in this ground-breaking sector. These studies demonstrate the nation’s dedication to improving medical research and offering patients cutting-edge care. Currently there are more than 250 ongoing clinical trials on CAR T Cell therapy in China.
The number of CAR-T therapy trials in China surpassed those in the United States by 2018 as a result of this thriving ecosystem. As of June 2022, Chinese companies have conducted 342 clinical CAR-T trials. Malignancies of the B lineage were among the most prevalent manifestations. Two CAR-T products have commercial applications, Yescarta in June 2021 and Relma-cel in September 2021, among numerous drug candidates.
According to Frost & Sullivan, the domestic CAR-T market is projected to increase from CNY 0.2 billion in 2021 to CNY 8 billion in 2025, and then to CNY 28.9 billion in 2030, at a CAGR of 45% from 2022 to 2030. Despite the fact that the Chinese CAR-T market is still in its infancy, a robust driving force exists.
Although the two approved CAR-T products are from Sino-US joint ventures Fosun Kite and JW Terapeutics, domestic players have made breakthroughs and caught up to global players in recent years. Legend Biotech, IASO Biotherapeutics, and CARsgen Therapeutics all obtain NDA approval for their BCMA CAR-T products, establishing them as the leaders in BCMA CAR-T therapy. CD19 CAR-T products are a focus for Juventas Therapeutics, Gracell Biotechnologies, Hrain Biotechnology, ImunoPharm, Shanghai Cell Therapy Group, and numerous domestic companies. Juventas Therapeutics is the leader in Chinese CD19 CAR-T therapy now that the NMPA has accepted its NDA for CNCT19. CARsgen Therapeutics is a global leader in solid tumours, and CT041 is the first CAR-T candidate for treating solid tumours to enter Phase II clinical trials. Bioheng Biotech and BRL Biotech (Chinese: ) create new allogeneic CAR-T markets.
The State Drug Administration (“NMPA”) has conditionally approved the product of Fosun Kite Biotechnology Co., Ltd., jointly established by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma of the United States (trade name: Yikaida®) for the treatment of adult patients with large B-cell lymphoma (r/r LBCL) who failed first-line immunochemotherapy or relapsed within 12 months (“this new indication”). The formal debut of Yikaida® for second-line indication occurs at this time as well.
For the treatment of adult large B-cell lymphoma patients who did not react to first-line immunochemotherapy or who relapsed within a year of receiving it, there was previously no CAR-T cell therapy product available in China. A second-line indication was added by Fosun Kite’s Yikaida®. The drug’s approval for marketing has successfully sparked new developments in the management of adult large B-cell lymphoma, giving hope to more patients whose first-line immunochemotherapy has failed or relapsed. The first CAR-T cell therapy product to be licenced in China for this new indication is now Yikaida®.
For adult patients with relapsed or refractory multiple myeloma (RRMM) who have had at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, FUCASO is the first fully-human BCMA-directed chimeric antigen receptor (CAR) T-cell therapy.
A BCMA-directed CAR T cell treatment called FUCASO (Equecabtagene Autoleucel) uses lentivirus as a gene vector to transfect autologous T cells. A fully human scFv, CD8a hinge and transmembrane, 4-1BB-mediated co-stimulation, and CD3 activation domains are all present in the CAR.
FUCASO has showed quick and powerful efficacy as well as prolonged persistency in RRMM patients, delivering higher and deeper responses and long-term clinical benefit, based on selection and screening of the molecular structures, in vivo and in vitro evaluation. The combined development and marketing of FUCASO for the treatment of RRMM in China is the work of Innovent and IASO Bio.
The FUMANBA-1 clinical study, a multi-center phase I/II registrational clinical trial undertaken in China to assess the efficacy of equecabtagene autoleucel in patients with RRMM, was the basis for the NDA approval.
Clinical studies for CAR-T cell therapy have advanced significantly in China, where multiple eminent institutes have led ground-breaking study. These clinical trials are designed to assess the efficacy of CAR-T cell therapy in the management of solid tumours, leukaemia, and lymphoma.
Image: One of the hospital’s that runs clinical trials on Car T-cell therapy in China.
A significant study at the Peking University Cancer Hospital examined the use of CAR-T cells to treat acute lymphoblastic leukaemia (ALL) that has relapsed or is resistant to treatment. The research showed promise for CAR-T cell therapy as an effective treatment choice for patients with few other options thanks to its outstanding remission rates.
Additionally, a number of clinical trials have been conducted in China to examine the use of CAR-T cell treatment in solid tumours, a difficult condition with a historically low response to immunotherapies. These trials make use of cutting-edge techniques to increase CAR-T cell efficacy and get around the immunosuppressive tumour microenvironment.
International partnerships have contributed to the clinical trials of CAR-T cell therapy’s success in China. Chinese scholars have worked with well-known organisations all around the world to exchange knowledge and experience, advancing this discipline. Such collaborations have aided in the creation of sophisticated CAR-T cell therapies, including the investigation of combinatorial therapies and the use of cutting-edge gene-editing methods.
Chinese researchers have also been in the forefront of the development of off-the-shelf CAR-T cell products in an effort to circumvent the logistical difficulties posed by personalised CAR-T cell therapy. If successful, these universal CAR-T cell products could provide patients all over the world a more convenient and affordable therapeutic alternative.
The CAR-T cell therapy clinical trials done in China are evidence of the nation’s dedication to developing medical research and enhancing patient outcomes. These trials have the potential to change the face of cancer treatment by showing excellent outcomes in treating both haematological malignancies and solid tumours, providing new hope for patients everywhere.
The goal of CAR T-cell therapy is to specifically target cancer cells by reprogramming a patient’s T-cells, which are part of their immune system. In treating hematological malignancies, such as leukemia and lymphoma, where conventional medicines have frequently failed, this individualized therapeutic method has shown encouraging outcomes.
The use of chimeric antigen receptor (CAR) T-cell treatments in the treatment of hematological malignancies has been incredibly effective. The application of CAR T-cell treatments has grown in China over the past nine years.
The first CAR T cell clinical studies started in 2013, and by 2017 there were more CAR T cell clinical trials than ever before. Soon after, China announced that it would provide a total of US$237 billion in funding for cell therapy businesses in 2021, which represented a huge increase in the number of clinical trials and fundamental research projects involving CAR T cells.
Strong government support, money inflow, high patient demand, a distinctive healthcare system, and the efforts of Chinese doctors and scientists all contributed to this significant surge in activity in China.
With more 350 ongoing clinical trials on CAR T-Cell therapy, China has achieved great strides. Innovative CAR T-cell therapies have been actively developed and tested by Chinese researchers and medical institutes, with a focus on both solid tumours and haematological malignancies. In terms of CAR T cell therapy developments, China has been in the vanguard, and there are numerous cutting-edge clinical trials happening there. Because of this, patients looking to access the most recent developments in CAR T cell therapy may find China to be an appealing alternative..
CAR T-Cell therapy cost in China is significantly lower than that in countries like US, UK, Australia, Japan, Korea and Singapore. CAR T-Cell therapy in China may cost just $ 60,000 USD. China has a comparatively high availability of CAR T cell therapy. There may be shorter treatment wait periods now that more medical facilities in China have received regulatory authorization to provide CAR T cell therapy. In addition, CAR T cell therapy is frequently less expensive in China than it is in other places, like the United States. This element may be especially important for people looking for affordable treatment choices.
Due to its participation in multiple clinical trials and therapies, China has developed a significant amount of knowledge and experience in providing CAR T cell therapy. Chinese medical experts have improved their knowledge of CAR T cell therapy-related problems and their ability to manage them in order to improve patient outcomes. China offers high-quality healthcare thanks to its vast patient population, supportive infrastructure, and collected knowledge in CAR T cell therapy.
In recent years, American businesses have begun collaborating with their Chinese counterparts to develop CAR T cell medicines. For ex. In 2015, WuXi AppTec, a Chinese contract research organisation (CRO), and Juno Therapeutics, a US-based biopharmaceutical business, partnered strategically. Chinese biopharmaceutical company Cellular Biomedicine Group worked with US biopharmaceutical company Celgene, which is now a division of Bristol-Myers Squibb. A global partnership and licence deal was made between Janssen Biotech, a pharmaceutical firm owned by Johnson & Johnson, and Legend Biotech, a business with operations in both China and the US.
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Once our team receives your medical reports, we analyze them and send it to hospitals that are performing CAR T-Cell therapy with that type of cancer and marker. We send reports to the concerned specialist and get his opinion. We also get estimate from the hospital on complete treatment. This helps you in planning for the entire treatment duration.
Once you decide to visit for the treatment, we arrange for medical visa letter and other necessary documents from the hospital. We also help and guide you in applying for medical visa to the Chinese embassy. Once visa is ready we help and guide you in preparing for travel and flight tickets. We also arrange for your hotel and guest house, if required in China. Upon arrival in the city of treatment our representative will welcome you at the airport.
Our representative will arrange for doctor appointment and complete the necessary registration formalities for you. He will also help you with your hospital admission and other local help and support that are required. After the treatment is over we will arrange for your follow up consultation with the treating doctor.
The innovative immunotherapy method known as CAR T-cell therapy has showed exceptional promise in the treatment of a variety of malignancies. Beijing, China’s Peking University Cancer Hospital has become a global leader in the development of CAR T-cell treatment. With the help of their multidisciplinary team, which consists of oncologists, immunologists, and geneticists, personalized cancer treatment has advanced significantly. Peking University Cancer Hospital has obtained outstanding outcomes in patients with haematological malignancies by altering patients’ own T cells to express chimeric antigen receptors (CARs). This cutting-edge treatment gives cancer patients fresh hope while revolutionizing the field of oncology and raising survival rates.
A prominent medical centre in Shanghai, China called Shanghai Changzheng Hospital has actively contributed to the development of CAR T-cell therapy. The creation and use of this ground-breaking cancer treatment have benefited greatly from their committed team of specialists and cutting-edge facilities. Changzheng Hospital has achieved outstanding results in the treatment of haematological malignancies, including leukaemia and lymphoma, by genetically altering patient T cells to express CARs. They are at the forefront of CAR T-cell treatment in China thanks to their dedication to research, clinical studies, and patient care. Shanghai Changzheng Hospital is making progress in this ground-breaking area and giving cancer patients and their families new hope.
Beijing, China’s Lu Daopei Hospital has significantly advanced the field of CAR T-cell treatment. Lu Daopei Hospital, which places a high priority on cancer treatment and research, has been at the forefront of applying CAR T-cell therapy to treat haematological malignancies. Oncologists, immunologists, and geneticists on their team have been committed to completing clinical trials and creating patient-specific CAR T-cell therapy. Lu Daopei Hospital has seen encouraging improvements in patient outcomes and survival rates because to their knowledge and cutting-edge facilities. Their work continues to influence how cancer is treated, opening up fresh opportunities for patients who are in need of hope. Till date they claim to have done more than 1000 CAR T-Cell therapy infusions.
In the field of CAR T-cell treatment, the First Affiliated Hospital of Zhengzhou University, situated in Zhengzhou, China, has become a well-known organisation. The hospital has made tremendous progress in maximising the potential of CAR T-cell therapy for patients by placing a major emphasis on cutting-edge cancer treatments. Oncologists, immunologists, geneticists, and other members of their interdisciplinary medical staff have all taken an active part in studies and clinical trials. The facility has treated haematological malignancies with impressive success thanks to the use of CAR T-cell therapy. As personalised cancer therapy develops, The First Affiliated Hospital of Zhengzhou University is in the forefront, giving patients fresh hope and a better quality of life.
Take expert second opinion on CAR T-Cell therapy infusion from best researchers in China.
Hematology
Profile: Clinical professor and medical executive president of Lu Daopei hospital in China. She has had many awards which including National Cancer Institute individual fellowship award, physician scientist award (K011) from National Cancer institute.
Cell therapy & Immunology
Profile: Dr. Zhang was professor at the University of Florida School of Medicine, used to be a senior professor of immunology at the Moffitt Cancer Center in Florida, the United Nations Nuclear Energy Commission (IAEA) AIDS cancer research expert consultant, and the US Food and Drug Administration (FDA) gene cell therapy expert consultant.
Immune Cell therapy
Profile: Engaged in tumor immune cell therapy research and development and inspection and testing for 8 years, participated in the publication of 15 SCI papers in internationally renowned journals, participated in the compilation of 1 Chinese and English books; applied for 9 national invention patents.
Cost of CAR T-Cell therapy in China starts from $ 45,000 USD and can reach up to $ 80,000 USD depending upon the type and extent of disease and its burden on the body. It is crucial to keep in mind that this estimate is only a general approximation and that specific circumstances may change. The precise type of CAR-T therapy, the intricacy of the procedure, hospital costs, supportive care, and additional diagnostic testing are all variables that can affect price. To control the costs related to CAR-T cell therapy, it is advised for patients to speak with healthcare professionals and look into insurance coverage or financial help programmes.
Chimeric antigen receptor T-cell therapy, often known as CAR T-cell therapy, is a ground-breaking immunotherapy that has completely changed the way that cancer is treated. It gives patients with certain cancers hope that were previously seen as incurable or with few therapeutic alternatives.
The treatment entails using a patient’s own immune cells—more specifically, T cells—and lab-modifying them to improve their capacity to detect and destroy cancer cells. To do this, the T cells are given a chimeric antigen receptor (CAR), which gives them the ability to target particular proteins, or antigens, on the surface of cancer cells.
T cells from the patient are first removed, and they are then genetically modified to express the CAR. In the laboratory, these altered cells are multiplied to produce a sizable population of CAR T cells, which are then put back into the patient’s bloodstream.
As soon as they are inside the body, CAR T cells find cancer cells that express the desired antigen, attach to them, and trigger a potent immune response. The CAR T cells that have been activated proliferate and conduct a focused attack on the cancer cells, killing them.
When used to treat some blood malignancies like acute lymphoblastic leukaemia (ALL) and specific forms of lymphoma, CAR T-cell therapy has shown exceptional results. It has produced notable response rates and in some patients, even long-lasting remissions.
CAR T-cell therapy, however, is a sophisticated and unique therapeutic method that might have risks and adverse effects. Cytokine release syndrome (CRS), a widespread immunological reaction that can result in flu-like symptoms and, in extreme situations, organ failure, may be experienced by certain people. There have also been reports of neurological adverse effects, however they are frequently curable.
Despite these difficulties, CAR T-cell therapy is a significant advancement in the fight against cancer and shows great potential for the future. Current studies are focused on enhancing its efficacy and safety profile as well as extending its uses to different cancer types. CAR T-cell therapy has the ability to change the face of cancer treatment and give patients everywhere new hope with further advancements.
T cells are extracted from your blood using a tube that is placed into an arm vein. This takes a couple of hours.
T cells are transported to a facility where they undergo genetic modification to become CAR-T cells. Two to three weeks pass throughout this.
CAR-T cells are reintroduced into your bloodstream through a drip. This requires several hours.
CAR-T cells target and eliminate cancer cells throughout the body. After receiving CAR-T therapy, you will be closely watched.
Only patients with adult B-cell non-lymphoma Hodgkin’s or pediatric acute lymphoblastic leukemia who have already tried two unsuccessful conventional therapies can currently use CAR T-cell therapy products that have received FDA approval. However, CAR T-cell therapy is now being tested in clinical studies as a first or second-line treatment for adult lymphoma and pediatric acute lymphoblastic leukemia. Recently, some of the studies have shown remarkable successes in cases of solid tumors too like glioblastoma, gliomas, liver cancer, lung cancer, GI cancer, pancreatic cancer and oral cancers.
This represents a significant advancement in the management of leukemia and B-cell lymphoma. Additionally, it gives hope to those whose lives had previously been predicted to last only six months. Now that we have identified mechanisms of resistance and created more techniques to combat them, the future appears to be much more promising.
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The main benefit is that CAR T-cell therapy only requires a single infusion and often only requires two weeks of inpatient care. Patients with non-Hodgkin lymphoma and pediatric leukemia who have just been diagnosed, on the other hand, typically need chemotherapy for at least six months or more.
The advantages of CAR T-cell therapy, which is actually a living medication, can persist for many years. If and when a relapse occurs, the cells will still be able to identify and target cancer cells because they can survive in the body for an extended period of time.
Although the information is still developing, 42% of adult lymphoma patients who underwent CD19 CAR T-cell treatment were still in remission after 15 months. And after six months, two-thirds of patients with pediatric acute lymphoblastic leukemia were still in remission. Unfortunately, these patients had exceedingly aggressive tumors that weren’t successfully treated using traditional standards of care.
Patients between the age of 3 Years to 70 Years have been tried with CAR T-Cell therapy for different type of blood cancers and has been found to be very effective. Many centers have claimed success rates of more than 80%. The optimum candidate for CAR T-cell therapy at this time is a juvenile with acute lymphoblastic leukemia or an adult with severe B-cell lymphoma who has already had two lines of ineffective therapy.
Before the end of 2017, there was no accepted standard of care for patients who had already gone through two lines of therapy without experiencing remission. The only FDA-approved treatment that has so far proven to be significantly beneficial for these patients is CAR T-cell therapy.
CAR T-cell therapy has been very effective in treating some types of blood cancer, like acute lymphoblastic leukaemia (ALL) and non-Hodgkin lymphoma. In clinical trials, the response rates have been very good, and a lot of patients have gone into full remission. In some cases, people who had tried every other medicine had long-lasting remissions or even possible cures.
One of the best things about CAR T-cell treatment is that it targets the right cells. The CAR receptors that have been added to the T cells can find specific marks on cancer cells. This makes it possible to give targeted treatment. This targeted method hurts healthy cells as little as possible and lowers the risk of side effects that come with traditional treatments like chemotherapy.
But it’s important to keep in mind that CAR T-cell therapy is still a new area that is still changing. Researchers and doctors are working hard to solve problems like the high cost, the possibility of serious side effects, and the fact that it only works for some types of cancer.
In the end, CAR T-cell therapy has shown to be a very successful way to treat some types of blood cancer. Even though it is a promising and powerful method, more study and clinical trials are needed to improve it and find new ways to use it. CAR T-cell therapy could change how cancer is treated and make things better for people all over the world if it keeps getting better.
1. Patients with CD19+ B-cell Lymphoma(At least 2 prior combination chemotherapy regimens)
2. To be aged 3 to 75 years
3. ECOG score ≤2
4. Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
1. Intracranial hypertension or unconsciousness
2. Respiratory failure
3. Disseminated intravascular coagulation
4. Hematosepsis or Uncontrolled active infection
5. Uncontrolled diabetes.
B-cell precursor acute lymphoblastic leukemia, relapsed or refractory diffuse large B-cell lymphoma
Complete response rate (CR): >90%
Target: CD19
Price: $475,000
Approval time: August 30, 2017
Relapsed or refractory diffuse large B-cell lymphoma, relapsed or refractory follicular cell lymphoma
Non-Hodgkin’s lymphoma Complete response rate (CR): 51%
Target: CD19
Price: $373,000
Approval time: 2017 October 18
Relapsed or refractory diffuse large B-cell lymphoma
Mantle cell lymphoma Complete response rate (CR): 67%
Target: CD19
Price: $373,000
Approved time: October 18, 2017
Relapsed or refractory diffuse large B-cell lymphoma
Complete response rate (CR): 54%
Target: CD19
Price: $410,300
Approved time: October 18, 2017
Relapsed or Refractory Multiple Myeloma
Complete response rate: 28%
Target: CD19
Price: $419,500
Approved: October 18, 2017
Below mentioned are some of the side-effects of CAR T-Cell therapy.
It’s important to remember that not every patient will have these side effects, and that each person’s level of sensitivity will differ. In order to minimize and minimize these potential adverse effects, the medical team closely examines patients before, during, and after CAR T-cell therapy.
Check below the total time frame required for complete the CAR T-Cell therapy process. Although time frame depends a lot on the distance of lab from the hospital that prepared the CAR’s.
Total time frame: 10-12 Weeks
The Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
The Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.
The Food and Drug Administration approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.
The Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg.
The Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda).
