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Tags Archives: Future Of Medicine


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7 months ago patient story

🍀Чудесное путешествие через границы: триумф мистера Баранкова с китайской терапией CAR-T🍀

🍀Чудесное путешествие через границы: триумф мистера Баранкова с китайской терапией CAR-T🍀

ЧудесноеПутешествие

ЧудесноеПутешествие

🌿Познакомьтесь с мистером Баранковым,

68-летним пациентом из Санкт-Петербурга, Россия, который внезапно был диагностирован с множественной миеломой в 2018 году. После четырех лет международных консультаций он обнаружил, что Китай значительно продвинулся в области терапии CAR-T по сравнению с европейскими медицинскими учреждениями в Испании, Мюнхене, Гейдельберге и других странах. Результаты лечения в Китае ведущие в мире.

 

🌱После четырех лет лечения и рецидивов

После неудачной традиционной химиотерапии и двух автологичных трансплантаций гемопоэтических стволовых клеток, у него появилась возможность провести онлайн-консультацию с экспертами Международной больницы Цзяхуи в Шанхае. Во время виртуальной консультации господин Баранков был впечатлен опытом китайской медицинской команды и потенциалом лечения с помощью полностью человеческого препарата CAR-T FUCASO (Eque-cel). Учитывая лидирующее положение Китая в области терапии CAR-T, более конкурентоспособные затраты и относительно короткое время ожидания, господин Баранков принял решение отправиться в Китай для получения лечения.

☘️
#ЧудесноеПутешествие #ТерапияCART #ПересечениеГраниц #MiracleJourney #CARTTherapy #CrossingBorders #CART #Hopeofpatients #FUCASOApproval #Equecel #MultipleMyeloma #JiahuiHospital #Shanghai #Immunotherapy #MedicalInnovation #MedicalBreakthrough #CancerTreatment #FullyHumanCART


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8 months ago CAR-T

Exciting News Alert! China’s New TCR-T Product IND Approved for Synovial Sarcoma!

🌟 Exciting News Alert! China’s New TCR-T Product IND Approved for Synovial Sarcoma! 🌟

synovial sarcoma

synovial sarcoma

“Engineered T Cell Receptor-T Cell Therapy,” or “TCR-T (engineered T cell receptor-T cell, TCR-T) cell therapy,” involves the extraction of peripheral blood mononuclear cell (PBMC) samples from patients, followed by genetic engineering to introduce selected high-affinity T cell receptors (TCRs) into T cells. This enables them to seek out and specifically recognize tumor antigens, effectively targeting and killing cancer cells.
In early 2022, the Food and Drug Administration (FDA) in the United States approved a TCR-T therapy called “Kimmtrack” for treating uveal melanoma, marking a significant milestone in solid tumor treatment.
 
Recently, the prestigious international journal “Cell Rep Med” reported the Phase I clinical trial results of China’s first investigational new drug (IND) approved by the FDA for TCR-T cell therapy — TAEST16001. This groundbreaking research represents a crucial step forward in the clinical translation of adoptive T cell immunotherapy for advanced soft tissue sarcoma and holds the potential to become the world’s second marketed TCR-T cell therapy targeting solid tumors!
Cell Rep Med

Cell Rep Med

China’s first TCR-T product IND approval takes aim at synovial sarcoma.

TAEST16001,

           developed independently by Xiangxue Life Sciences, is a TCR-T cell product. The Phase I clinical trial enrolled 12 patients with advanced soft tissue sarcomas who were HLA-A*02:01 positive and expressed the NY-ESO-1 antigen. Among them, 10 patients had synovial sarcoma, while 2 had liposarcoma (1 myxoid liposarcoma and 1 dedifferentiated liposarcoma), with a median age of 33 (25-67) years. 58.3% (7/12) of patients were male. Before enrollment, 83.3% of patients had received at least two types of chemotherapy. After enrollment, all patients underwent modified lymphocyte clearance surgery followed by infusion treatment with TAEST16001 cells.
 
After a median treatment duration of 43 days, 9 out of 12 patients (75%) showed tumor regression (Figure 1), with a median time to response (TTR) of 1.9 months and a median duration of response of 13.1 months. Six patients (50%) exhibited sustained tumor burden reduction after the first radiological assessment. In the primary analysis, 5 out of 12 patients achieved partial responses, resulting in an objective response rate (ORR) of 41.7% (95% CI, 15.2–72.3). Disease stabilization was observed in 5 cases [41.7% (95% CI, 15.2–72.3)], yielding a disease control rate of 83.3% (95% CI, 51.6–97.9). The median progression-free survival (PFS) was 7.2 months (95% CI, 2.5–11.8).
TCR-T Therapy

TCR-T Therapy

How to Seek TCR-T Therapy Assistance

Several TCR-T therapies under development in China are urgently recruiting patients with hepatitis B virus-related liver hepatocellular carcinoma, head and neck tumors (oral cancer, laryngeal cancer, etc.), advanced cervical cancer, and anal cancer.
If you wish to assess whether your condition is suitable for CAR-T therapy, you can submit your pathological reports, treatment history, and discharge summaries to
<Advanced Medicine in China> doctor.huang@globecancer.com for preliminary evaluation.
or click on the WhatsApp+8613717959070
 
Stay tuned for more updates on this groundbreaking advancement in cancer treatment! 🌟
 
#CancerResearch #TCRTtherapy #SynovialSarcoma #MedicalInnovation


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9 months ago CAR-T

Chinese Hengrui Pharmaceuticals ‘s indication for cervical cancer has been approved for clinical trials.

🌟 Chinese Hengrui Pharmaceuticals ‘s indication for cervical cancer has been approved for clinical trials.🌟

cervical cancer

cervical cancer

🏥💊(Jiangsu Hengrui Pharmaceuticals Co., Ltd)Hengrui Pharmaceutical’s PD-L1 inhibitor Atezolizumab injection combined with concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer has been approved for open, multicenter Phase II clinical trials.
Atezolizumab

Atezolizumab

🌸🎀#Cervical cancer is the fourth most common cancer in women globally, mainly caused by persistent infection with high-risk human papillomavirus (#HPV). Although the widespread implementation of #cervicalcancer screening and the availability of HPV vaccines have reduced the incidence of cervical cancer in developed countries, it remains one of the common malignant tumors in women.
 
🏥💊Atezolizumab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Medicine. It is the first PD-L1 inhibitor approved for the treatment of small cell lung cancer in China. By specifically binding to the PD-L1 molecule, it blocks the PD-1/PD-L1 pathway that leads to tumor immune tolerance, reactivating the immune system’s anti-tumor activity and achieving the goal of tumor treatment.
The Lancet Oncology

The Lancet Oncology

🌸🎀Atezolizumab injection has been studied in various fields, including small cell lung cancer, #NSCLC non-small cell lung cancer, esophageal cancer, liver cancer, and cervical cancer. It has shown promising efficacy in small cell lung cancer. Based on the results of the SHR-1316-III-301 study, the application for the market approval of Atezolizumab injection combined with chemotherapy as first-line treatment for extensive-stage small cell lung cancer has been accepted and approved in China in March 2023. The study results have been published in the top international medical journal “The Lancet Oncology,” and the original research from China has been internationally recognized.

🏢💊Jiangsu Hengrui Pharmaceuticals Co., Ltd is committed to advancing the clinical research of the PD-L1 inhibitor Atezolizumab injection, bringing more innovative and effective treatment options for cervical cancer patients. Stay tuned for our progress!
Hengrui Pharmaceutical

Hengrui Pharmaceutical

🚑In addition to Cervical cancer, we are currently urgently recruiting patients with B-cell lymphoma, T-cell lymphoma, T-cell leukemia (T-ALL), acute lymphoblastic leukemia, myeloma, and other types of cancer!

You can send electronic copies or photos of genetic testing reports and diagnostic reports to the 📩email address: doctor.huang@globecancer.com📩, or click on the ✉️WhatsApp+8613717959070✉️ icon on the homepage. The Medical Department will contact you as soon as they receive the reports.

#CervicalCancerTreatment #Atezolizumab #HengruiMedicine #ClinicalTrials #CancerTreatment #cervical #cervicalcancer #chinesemedicine #newdrug #Lancet #TheLancetOncology
 
📩References:  
[1]gco.iarc.fr(WHO statistics)
  [2]Rose PG,Bundy BN,Watkins EB,Thigpen JT,Deppe G,Maiman MA,Clarke-Pearson DL,Insalaco S:Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer.N Engl J Med1999,340(15):1144-1153.
  [3]Pfaendler KS,Tewari KS:Changing paradigms in the systemic treatment of advanced cervical cancer.Am J Obstet Gynecol2016,214(1):22-30.
  [4]Liu C,Lu J,Tian H,Du W,Zhao L,Feng J,Yuan D,Li Z:Increased expression of PDL1by the human papillomavirus16E7oncoprotein inhibits anticancer immunity.Mol Med Rep2017,15(3):1063-1070.


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9 months ago CAR-T

Chinese Exciting Good News Update in Lung Cancer Treatment! ORR: 78.6%

🌟 Chinese Exciting Good News Update in Lung Cancer Treatment! ORR: 78.6%🌟

👨‍⚕️Meet Sunvozertinib, the game-changer in advanced lung cancer therapy! 👨‍⚕️

Sunvozertinib,NSCLC

Sunvozertinib, NSCLC

🚀 This groundbreaking oral medication, a novel irreversible EGFR-TKI, targets multiple EGFR mutation subtypes with remarkable precision. What’s more? Sunvozertinib is now the FIRST and ONLY EGFR-TKI approved for treating late-stage NSCLC with EGFR exon20ins mutations! 💊💥
At the 2023 ESMO Conference, fresh data from early trials of Sunvozertinib’s frontline treatment for EGFR exon20ins-mutated advanced NSCLC were unveiled, and the results were jaw-dropping! 📊🔬 With an astounding Objective Response Rate (ORR) of 78.6% and a median Progression-Free Survival (PFS) of 12.4 months at the recommended dose (300mg QD), Sunvozertinib once again set a new benchmark in this field, offering a superior treatment option for newly diagnosed patients with EGFR exon20ins mutations! 🌟💪
Let’s dive into a real success story: A 35-year-old male diagnosed with late-stage NSCLC harboring EGFR exon20ins mutations, along with metastases to the brain, liver, and bones. After showing stable disease (SD) following two cycles of platinum-based chemotherapy, he switched to Sunvozertinib. Just one month into treatment, a follow-up chest CT scan revealed a remarkable 34% reduction in the size of the left lower lobe lesion, with lung lesions shrinking from 29mm×26mm to 19mm×15mm (see image). Multiple nodules in the lungs and pleura also decreased in size, along with liver lesions. Evaluation: Partial Response (PR)! 🌟🔍
Lung Cancer

Lung Cancer

Noteworthy is the impeccable safety profile of Sunvozertinib, with no significant adverse effects reported during treatment. As of this post, the patient continues to receive Sunvozertinib monotherapy with promising outcomes! 🌟👏
With breakthroughs in targeted therapies for EGFR exon20ins-mutated NSCLC, several new drugs are actively exploring frontline treatment options. The early study results of Sunvozertinib’s frontline therapy for EGFR exon20ins-mutated advanced NSCLC have once again rewritten the records in this field, providing new treatment guidelines for these patients! 📈💡


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9 months ago CAR-T

Breakthrough in Cancer Treatment in CHINA: TX103 CAR-T Approved for Clinical Use Against Recurrent Brain Gliomas

🔬”Breakthrough in Cancer Treatment in CHINA: TX103 CAR-T Approved for Clinical Use Against Recurrent Brain Gliomas”🔬🧠

Brain Gliomas

Brain Gliomas

✨ Exciting news in cancer research! Fuzhou Tuoxin Tiancheng Biotech’s TX103 CAR-T, a revolutionary therapy for recurrent stage 4 gliomas, has received clinical approval. 🌟 🧠

#CancerTreatment #MedicalInnovation #TX103CAR_T #CAR_T #Tumor #solidtumor #brainglioma #glioma
 

Article:

Fuzhou Tuoxin Tiancheng Biotech Co., Ltd. (“Tuoxin Tiancheng”) has achieved a significant milestone with the clinical approval of their “TX103 Chimeric Antigen Receptor T-cell Injection” (TX103 CAR-T) for the treatment of recurrent or progressive stage 4 brain gliomas.🧠
 
TX103 CAR-T is a targeted therapy focusing on B7-H3. The B7-H3 target belongs to the B7 ligand family, showing excessive expression in various cancers while maintaining low or no expression in normal tissues. B7-H3 possesses non-immunogenic functions such as promoting migration and invasion, angiogenesis, chemotherapy resistance, endothelial-to-mesenchymal transition, and influencing tumor cell metabolism. Its expression in tumors is associated with poor prognosis, making it valuable in tumor immunotherapy.🧠
 
The therapy has already been approved for clinical trials in both China and the United States, with this recent approval marking a new indication. In August 2022, TX103 received clinical approval for the treatment of late-stage solid tumor patients who are TX103 positive, have failed standard treatments, or experienced intolerable toxicity after standard treatments with a confirmed pathological diagnosis.🧠
 
In September of the previous year, Tuoxin Tiancheng announced that their TX103 CAR-T cells, in collaboration with Tcelltech in the United States, received FDA approval for Investigational New Drug (IND) status for the treatment of malignant brain gliomas. This achievement represents a crucial milestone in Tuoxin Tiancheng’s efforts to address solid tumor treatments and promote internationalization. According to a Tuoxin Tiancheng press release, early clinical trial studies with TX103 in treating recurrent malignant brain gliomas demonstrated promising safety and efficacy signals. Furthermore, TX103 CAR-T for the treatment of malignant brain gliomas received orphan drug designation from the FDA in June 2023.🧠
Tuoxin Tiancheng

Tuoxin Tiancheng

Tuoxin Tiancheng is a clinical-stage innovative biopharmaceutical company focused on developing T cell immunotherapy products. Founded by Professor Chen Lieping, a pioneer in tumor immunology, and Professor Huang Gangxiong, an expert in immunotherapy, the company is dedicated to advancing innovative technologies and drugs in tumor immunotherapy and immunocellular therapy. With a professional team covering scientific research, technical development, quality management, production processes and registration, the company has taken a significant step forward with this clinical approval. We look forward to Tuoxin Tiancheng bringing more cutting-edge products to benefit patients. 🧠
#BiopharmaInnovation #ImmunotherapyAdvancement #TuoxinTianchengBiotech #chinesemedicine


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9 months ago CAR-T

Breakthrough in Reducing Lupus with Successful Application of CAR-T Dual Target Technology

🌈Breakthrough in Reducing Lupus with Successful Application of CAR-T Dual Target Technology 🌟

Lupus

Lupus

🏥 The Zhongshan City People’s Hospital has successfully employed CAR-T dual-target technology to cure a patient suffering from refractory systemic lupus erythematosus (SLE). This marks the world’s first successful case, providing a groundbreaking avenue for future treatments of similar diseases.
 
👩‍⚕️ Yin, a 29-year-old patient, was diagnosed with lupus in 2015. Despite seeking treatment in multiple hospitals and undergoing various therapies, including a cranial surgery in 2021, her condition worsened, leading to lupus nephritis and neurological complications. Then came the revolutionary CAR-T therapy.
 
💡 Dr. He, the patient’s doctor, explained: “After the seventh attempt with traditional treatments, the patient’s urinary protein did not decrease, and lung lesions appeared. Traditional and biological treatments were not effective, so we decided to try CAR-T therapy. This process involves culturing lymphocytes outside the body that can produce human immune factors. Using genetic engineering, we make them cells with targeted killing capabilities. These cells are then reintroduced into the patient’s body, selectively eliminating ‘pathogenic seeds.'”
Lupus

Lupus

 

🙌 Yin expressed her gratitude, saying: “The red spots on my body have disappeared, and I no longer need hormone medications or immunosuppressants. My mental state is also great, and all indicators are excellent. Today is my third checkup, and the results of the first two were also very positive. I thank these healthcare professionals for giving me a second life.”

 
#CARTTreatment #LupusBreakthrough #MedicalMiracle #HealthcareInnovation #CART #Lupus


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9 months ago CAR-T

Revolutionizing Medicine: CAR-T Therapy Beyond Cancer

🚀Revolutionizing Medicine: CAR-T Therapy Beyond Cancer 🚀

🔬 Over the past decade, CAR-T cell therapy has transformed the field of oncology, successfully treating previously incurable blood cancers. While CAR-T therapy gained fame for its success in cancer treatment, the roots of this groundbreaking principle trace back nearly 30 years—initially exploring T cell therapy for HIV/AIDS. Although the early attempts didn’t succeed in treating HIV/AIDS, they demonstrated the enduring potential of engineered T cells in immunocompromised patients.
 
🌟 CAR-T therapy,  or Chimeric Antigen Receptor T-cell Immunotherapy, essentially involves reengineering a patient’s immune T cells outside the body to recognize antigens on the surface of tumor cells. These modified cells are then reintroduced into the patient, effectively identifying and eliminating cancer cells. Scientists have been tirelessly working to extend CAR-T therapy beyond blood cancers to various other types.
 
💡 Moreover, research from both clinical and preclinical studies indicates that CAR-T therapy holds great promise beyond cancer treatment. It shows potential applications in autoimmune diseases, chronic infections, heart diseases, aging-related conditions, and more.
 
🌐 In recent years, scientists have focused on applying CAR-T therapy to solid tumors, exploring its potential in cancer types beyond blood-related malignancies. Early research results suggest that the next frontier for CAR-T therapy may extend to various fields outside cancer, including autoimmune diseases (systemic lupus erythematosus, pemphigus vulgaris, multiple sclerosis, type 1 diabetes, asthma), fibrotic diseases (fibrosis in the heart, liver, lungs, and kidneys), aging-related conditions (liver fibrosis, solid tumors, atherosclerosis, natural aging), and infectious diseases (HIV/AIDS, hepatitis B and C, pulmonary tuberculosis).
 
🚀 The future of CAR-T therapy holds vast potential in reshaping the landscape of medical treatment, reaching far beyond the realms of cancer. Stay tuned for ground
 
#immunotherapyrevolution #CARTTherapy #MedicalInnovation #BeyondCancer #ImmunotherapyRevolution #CART #cancer #tumor #cancertreatment #tcell


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9 months ago CAR-T

Exciting breakthrough in Chinese pharmaceutical research!

[🔬🌏] Exciting breakthrough in Chinese pharmaceutical research!

Chinese medicial research

Chinese medicial research

💊Since 2019, China has witnessed a surge in phase 1 and 2 clinical trials, with a focus on addressing prevalent cancers like stomach, esophageal, and cervical cancers. The world is now turning its attention to China’s rapid emergence on the global stage of pharmaceutical innovation.

 

🌟 Key Highlights:

PD-1, PD-L1, VEGFR, EGFR, and HER2 are at the forefront of Chinese drug development.
PD-1/PD-L1 therapies have shown outstanding efficacy in Asian patients, gaining approvals for various cancer treatments. The influx of these therapies has increased accessibility to cancer immunotherapy, simultaneously driving market competition and reducing economic burdens for patients and healthcare systems.
 

🚀 2020 and Beyond:

Rapid growth in the development of VEGFR, EGFR, and HER2 pathways. The approval of AK104, a dual-specificity PD-1/CTLA-4 antibody for cervical cancer treatment, marks a milestone.
Innovative discoveries in clinical research for gastrointestinal tumor drug targets like CLDN18.2, including CLDN18.2–CD3, CLDN18.2–PD-L1, and CLDN18.2 antibody-drug conjugates, promise a bright future for cancer treatments.
 

🌿 Traditional Medicine Meets Innovation:

Local biopharmaceutical companies in China are shifting towards “First in Class.” FDA and NMPA approvals for novel drugs like PRJ1-3024, ORIN001, and JS004 showcase this shift.
Traditional Chinese Medicine (TCM) continues to play a vital role in oncology, with formulations like As2O3 displaying potent anti-tumor activity. TCM is gaining attention, actively researching and revealing its anti-cancer mechanisms.
 

🔍 Future of Cellular Therapy:

While most studies focus on hematologic cancers, China’s research on solid tumor cellular therapy is rapidly expanding.
Diverse targets in solid tumors (gastric, lung, and neural) include MSLN, GPC3, MUC1, and CLDN18.2.
China’s forefront research in cellular therapy faces challenges but remains promising. With more efforts and innovations, the hope is for more effective solid tumor treatments in the future.
 
🌐 #ChinaMedicalInnovation #DrugDevelopment #CancerTreatment #CellularTherapy #medicalresearch 


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9 months ago CAR-T

China Leading Global Advances in Breast Cancer Immunotherapy

🌟China Leading Global Advances in Breast Cancer Immunotherapy 🌟#ChinaInMedicine #BreastCancer

Breast Cancer

Breast Cancer

Since 2020, breast cancer has surpassed lung cancer, becoming the most common cancer globally with approximately 2.3 million new cases and 680,000 deaths annually. Despite improvements in traditional treatments like surgery, chemotherapy, and radiation, the mortality rate remains high. China’s Chimeric Antigen Receptor (CAR) immunotherapy is making significant strides, spearheading innovation in breast cancer treatment. 🇨🇳💪
 
Recent studies indicate substantial breakthroughs in CAR-T therapy, as well as CAR-NK cells and CAR macrophages for breast cancer treatment. The application of combination therapies further enhances the cytotoxicity of CAR-based cell therapies against breast cancer cells, bringing new hope to patients. 🚀
 
China is at the forefront of global clinical research on CAR, with 16 clinical trials focused on CAR-T or CAR-NK cell therapies currently underway. Particularly noteworthy is the research at the People’s Liberation Army General Hospital, where CAR-T cells targeting CD133 are employed to treat refractory advanced malignant tumors, including breast cancer. This approach has demonstrated excellent anti-tumor activity and manageable safety in patients previously treated for advanced hepatocellular carcinoma and cholangiocarcinoma. 🏥✨
 
On another front, the clinical study at Sun Yat-sen Memorial Hospital, Zhongshan University, is equally intriguing. They are exploring PD-1 knockout CAR-T cells targeting MUC1 for treating late-stage breast cancer patients. This trial is a dose-escalation exploratory study, and researchers anticipate its results to pave the way for future treatments. 🧪🔍
 
China is not only a trailblazer in breast cancer immunotherapy research but also a miracle creator, bringing new hope to cancer patients worldwide. Let’s witness China’s outstanding achievements in the medical field and acknowledge its contribution to global health! 💊🌏
 
#ImmunotherapyAdvancements #BreastCancerResearch


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10 months ago CAR-T

Chinese Research: Hopes of CAR-T in Second-Line Treatment of LBCL(Lymphoma)

Diffuse Large B-cell Lymphoma (LBCL)is a heterogeneous malignant tumor of the blood system, with approximately 40% of LBCL patients experiencing relapse or developing resistance after first-line treatment, progressing to relapsed/refractory large B-cell lymphoma (R/R LBCL). In recent years, chimeric antigen receptor T-cell therapy targeting CD19 (CAR-T) has made significant breakthroughs in treating relapsed or refractory B-cell non-Hodgkin lymphoma.
At the 65th American Society of Hematology (ASH) Annual Meeting held from December 9th to 12th this year in the Eastern United States, important real-world evidence of CAR-T cell therapy as a second-line standard treatment for R/R LBCL was presented in the form of a poster (ASH Abstract #4876), providing crucial evidence-based medicine for the clinical application of CAR-T.
 
CAR-T Cell Therapy as Second-Line Treatment for R/R LBCL: Real-World
Evidence Among 110 patients receiving CAR-T infusion, the overall response rate (ORR) was 82.7%, and the complete response (CR) rate was 61.8%. Median progression-free survival (PFS) and overall survival (OS) were not reached. Estimated 6-month PFS and OS rates were 64.1% (95% CI, 52.8%-73.4%) and 84.4% (95% CI, 73.8%-90.9%), respectively.
The advent of CAR-T cell therapy has brought hope of cure for R/R LBCL patients. Based on its critical research and outstanding real-world application data, CAR-T cell therapy has gained recommendations from authoritative guidelines at home and abroad, and has become a crucial choice for second-line treatment in R/R LBCL patients.
 
#CARTCellTherapy #CancerTreatment #ScienceInnovation #GeneticMedicine #TumorTreatment #HealthcareTech #MedicalScience #CancerAwareness #PatientCare #FutureOfMedicine #CART #LBCL #Lymphoma #bloodcancer 

10 months ago CAR-T

The Emergence of Fifth Generation CAR-T: A Boon for Late-Stage Cancer Patients or a Major Breakthrough in Solid Tumor Treatment?

The fifth-generation CAR-T is designed as a universal type of CAR-T. Is this risk-free CAR-T capable of achieving significant breakthroughs in solid tumor treatment, or is it effectively reducing costs to enable scalable production and treatment?

After nearly three decades of development, CAR (Chimeric Antigen Receptor) technology has undergone continuous innovation. Currently, CAR has evolved to its fifth generation. Its aim is to enhance the safety of treatments by reducing toxicity and non-specific antigen recognition. This is achieved by stimulating proliferation, activation, and the generation of memory phenotypes within CAR-T cells to improve efficiency and provide immune regulation for the optimal function of CAR-T cells.

 

Generation CAR-T

Generation CAR-T

The Evolution of Different Generations of CAR-T

First Generation CAR:

The first-generation CAR comprises an extracellular single-chain variable fragment (scFv) as the antigen recognition binding domain and an intracellular CD3ζ as the cellular activation signaling domain. Despite initiating cytotoxic anti-tumor responses within transplanted T cells, first-generation CAR-T cells exhibit lower levels of cytotoxicity and proliferation due to the CAR structure lacking co-stimulatory domains, which results in inadequate interleukin (IL)-2 production.

 

Second Generation CAR:

Building upon the CD3ζ signal transduction domain, the second-generation CAR includes an additional co-stimulatory signaling domain that activates T cells, significantly enhancing T cell proliferation and survival. For instance, CD28 can deliver robust activation signals, enabling T cells to achieve high levels of cytotoxic activity in a shorter duration, while 4-1BB provides prolonged activation signals, sustaining T cell-mediated killing of tumor cells. However, limitations arise in second-generation CAR-T cells utilizing retroviruses as viral vectors, restricting the length of transgene fragments they can carry. As a result, it becomes necessary to choose between incorporating CD28 and 4-1BB into T lymphocytes.

 

Third Generation CAR:

Third-generation CAR-T cells utilize larger DNA-carrying lentiviruses as viral vectors, allowing simultaneous incorporation of DNA fragments for both CD28 and 4-1BB into T cells. Consequently, the third-generation CAR structure encompasses two co-stimulatory domains, theoretically addressing the need for higher activation intensity and sustained survival of CAR-T cells. However, the safety concerns associated with prolonged and high-level persistence of CAR-T cells, including potential attacks on the host’s immune system, remain unresolved despite these advancements.

 

Fourth Generation CAR:

The design concept behind the fourth-generation CAR revolves around the precise treatment of cancerous diseases. For instance, solid tumors generate a microenvironment (TME) during their chronic progression, preventing CAR-T cells from penetrating the tumor interior. As a result, CAR-T therapy demonstrates limited efficacy in treating solid tumors. TRUCK CAR-T involves incorporating cytokines (such as IL-12) or chemokines into the CAR structure. This facilitates increased infiltration of T cells into tumor tissues while recruiting other immune cells within the body to eliminate tumor cells. In some studies, a suicide gene or certain drug-sensitive genes are attached to the CAR structure to ensure the clearance of CAR-T cells from the body post-treatment, preventing inadvertent harm to normal cells and enhancing the safety and controllability of CAR-T therapy.

 

Fifth Generation CAR:

The fifth-generation CAR-T, known as universal CAR-T, achieves T-cell receptor α (TCR-α) and β (TCR-β) chain deletion by knocking out the TRAC gene. This implies the removal of the T-cell receptor (TCR) from the surface of T cells, thereby avoiding the occurrence of graft-versus-host disease (GVHD) in transplantation reactions.

Since the FDA’s approval of the CD19 CAR-T product, Novartis’s Kymriah, in 2017, CAR-T cell therapy has entered a stage of rapid development. However, the currently approved and marketed products are all second-generation CAR-T therapies. There is still a long way to go for CAR-T to become widespread in the market.

Safety concerns constitute the primary challenge for CAR-T, such as off-target effects, cytokine release syndrome (CRS), and neurotoxicity (NTX). Currently available CAR-T products primarily focus on treating hematologic malignancies, with no major breakthroughs achieved yet in treating solid tumors.

In 2021, China’s NMPA approved three CAR-T products for marketing: FOSUNKITE’s Axicabtagene Ciloleucel injection, JW Therapeutics’s Relmacabtagene Autoleucel Injection, and the recently approved JUVENTAS’s Inaticabtagene Autoleucel Injection, all targeting CD19. Additionally, earlier this year, IASO Bio obtained approval for Equecabtagene Autoleucel Injection, targeting BCMA. While CAR-T targeting CD19 has shown effectiveness, its scope remains limited to B-cell-related hematologic malignancies. BCMA-targeted CAR-T is restricted to treating multiple myeloma. To address solid tumor treatment, the development of more specific and potent targets is necessary.

Among the recently released domestically developed JUVENTAS’s Inaticabtagene Autoleucel Injection, its competitive advantage lies in its price, which has decreased to below one million RMB(Approximately $140,000 US).

With the continuous advancement of molecular biology technologies, more breakthroughs are expected in CAR molecule design. This progression anticipates the development of safer and more efficient universal CAR-T therapies in the future, benefiting a broader spectrum of cancer patients.

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