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CAR-T Cell Therapy as a New Option for Treating Multiple Myeloma
**CAR-T Cell Therapy as a New Option for Treating Multiple Myeloma**
“CAR-T cell therapy has now become a new option for treating patients with relapsed and refractory multiple myeloma, with hopes of changing the difficult situation in myeloma treatment where treatments are either ineffective or unavailable,” said Jin Jie, Director of the Hematology Department at the First Affiliated Hospital of Zhejiang University School of Medicine, in an interview with People’s Daily Health on October 23.
Early on October 23, Jin Jie visited the hospital ward to see a 72-year-old patient with multiple myeloma. Just the day before, the patient had begun receiving treatment with a domestically produced BCMA-targeting CAR-T drug.
“This 72-year-old patient came to the hospital due to bone pain and was even unable to walk steadily,” Jin recalled. After being diagnosed with multiple myeloma, the patient initially received a series of chemotherapy regimens that showed some efficacy. However, a year after undergoing autologous hematopoietic stem cell transplantation, the disease relapsed, and various subsequent treatments proved suboptimal. As a result, the patient opted for CAR-T therapy.
Since the approval of Equecabtagene Autoleucel last year, Professor Jin Jie became one of the first doctors nationwide to prescribe CAR-T drugs for multiple myeloma. This patient is her tenth multiple myeloma patient to receive this innovative therapy. Discussing the treatment outcomes, Jin noted, “The overall efficacy for patients has been very good.” A month ago, another patient who underwent this CAR-T therapy returned for a follow-up. “Everything was going well; we will continue to monitor the patient’s indicators until all data are stable.”
Multiple myeloma is a malignant plasma cell disease that predominantly affects older adults. Jin observed that the incidence of multiple myeloma has been trending younger in recent years, with patients in their forties commonly seen in clinical settings. Currently, multiple myeloma remains an incurable disease, and most patients face inevitable relapse. However, thanks to the emergence of new drugs and advances in treatment, both the efficacy and overall survival of patients have significantly improved in recent years.
“CAR-T therapy involves collecting a patient’s T cells and equipping them with a ‘weapon.’ These T cells are then expanded outside the body and re-infused into the patient, where they target and attack tumor cells, while also being able to proliferate in the patient’s body to eliminate cancer cells,” Jin explained. CAR-T therapy has the potential to give patients a higher quality of life.
CAR-T cell therapy has been advancing rapidly in the field of multiple myeloma, with multiple products already approved and available. In Jin’s view, patients should, under professional guidance, choose drugs and treatments with extensive clinical experience and proven efficacy.
🎉🎉To assess whether the condition is suitable for CAR-T therapy, you can submit pathology reports, treatment history, and discharge summaries to the Medical Department of <Advanced Medicine in China> for preliminary evaluation!
WhatsApp: Https://wa.me/+8613717959070
Email: doctor.huang@globecancer.com
**#MultipleMyeloma #CAR_TCellTherapy #CancerTreatment #Immunotherapy #Hematology #CellTherapy #MedicalInnovation #PatientCare #Oncology #ZhejiangUniversity**
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Redefining Hope for High-Risk RRMM Patients Worldwide: A Singaporean Patient`s Journey to China for Groundbreaking CAR-T Therapy
Redefining Hope for High-Risk RRMM Patients Worldwide: A Singaporean Patient`s Journey to China for Groundbreaking CAR-T Therapy
#MultipleMyeloma #CAR_Therapy #CancerTreatment #HRMM #MM #RRMM #CART
In the fight against multiple myeloma (MM), the last few decades have seen significant advancements, yet the disease remains notoriously difficult to cure, particularly in patients with relapsed/refractory multiple myeloma (RRMM). These patients face enormous challenges, as their options become increasingly limited after multiple lines of therapy have failed. However, hope has emerged in the form of BCMA CAR-T therapy, offering deep remission and long-term survival for those who had nearly lost hope.
One such case is a 58-year-old woman from Singapore, who after exhausting all available treatments in her home country, found new hope in China`s innovative CAR-T therapy. Diagnosed with MM in May 2021 following a month of severe back pain, she underwent a series of treatments including CD38 monoclonal antibodies, immunomodulatory drugs (IMiDs), proteasome inhibitors (PI), and XPO-1 inhibitors. Unfortunately, these therapies failed to halt the progression of her disease, which had become highly resistant to treatment.
In December 2023, she traveled to Beijing Chaoyang Hospital, Capital Medical University, where Professor Chen Wenming took charge of her case. The patient was diagnosed with high-risk MM (IgG-κ type) and admitted to the hospital on November 25, 2023, for CAR-T therapy.
#### The Treatment Journey: A Detailed Overview
Given the patient’s refractory nature and multiple prior treatments, Professor Chen devised a tailored treatment plan to improve her chances of survival and quality of life. In November 2023, her lymphocytes were collected to prepare the CAR-T cells. During this period, she received two cycles of D-PACE (dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide) chemotherapy in Singapore to control the extramedullary plasmacytoma.
In February 2024, she returned to Beijing for further evaluation, where her condition was assessed as showing minimal response (MR). She was then administered a lymphodepletion regimen of fludarabine and cyclophosphamide on February 29. The following month, she received a transfusion of BCMA CAR-T cells.
Within five days post-transfusion, the patient developed a fever, which peaked at 39°C. Fortunately, her oxygen saturation and heart rate remained normal, and she was diagnosed with Grade 1 cytokine release syndrome (CRS). After symptomatic treatment, her blood counts recovered by day 15, and she was discharged in stable condition.
Two weeks post-CAR-T therapy, her response was evaluated as a very good partial response (VGPR), and by the two-month mark, her condition had improved to complete remission (CR) with minimal residual disease (MRD) negativity.
#### Insights from Leading Experts
Professor Wee Joo Chng, a specialist in high-risk MM, noted the aggressive nature of the patient’s disease, marked by genetic abnormalities like 1q21+ and t(4;14). Despite the use of multiple potent therapies, including KRd, XVd, and Isa-Pd, the patient’s disease continued to progress rapidly. The emergence of the del(17p) mutation further complicated her prognosis, indicating the need for a novel therapeutic approach.
The FUMANBA-1 study has highlighted the effectiveness of China`s indigenous CAR-T product, Equecabtagene Autoleucel, in achieving deep remission and prolonging survival in RRMM patients. This case demonstrated the therapy`s potential to overcome poor prognostic factors and extend the patient’s survival. Notably, the patient experienced only mild CRS and no immune effector cell-associated neurotoxicity syndrome (ICANS) or infections during treatment. At the two-month follow-up, the patient’s condition had improved to CR with MRD negativity, suggesting that Equecabtagene Autoleucel could be a game-changer for high-risk RRMM patients.
#### A New Frontier in CAR-T Therapy
RRMM patients with double-hit characteristics often experience early relapse and progression, leading to shortened survival times. Traditional therapies, including IMiDs, PIs, and monoclonal antibodies, have failed to overcome these poor prognostic factors, indicating the urgent need for novel treatments. Real-world studies have shown that CAR-T therapy offers comparable progression-free survival (PFS) and overall survival (OS) rates in RRMM patients, regardless of high-risk cytogenetic abnormalities.
The FUMANBA-1 study revealed impressive outcomes for Equecabtagene Autoleucel in RRMM patients, with an overall response rate (ORR) of 98.9% and an MRD negativity rate of 97.8% among CAR-T-naive patients. The CR rate was 82.4%, and 81.7% of patients maintained MRD negativity for over a year.
Globally, four CAR-T products are currently available, and a recent study presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) compared the short- and long-term efficacy of these therapies. The study’s matching-adjusted indirect comparison (MAIC) analysis revealed that Equecabtagene Autoleucel had a 12-month PFS rate of 94.2%, higher than the 75% observed with Ciltacabtagene autoleucel (CARTITUDE-1 study). Furthermore, the 12-month sustained MRD negativity rate for Equecabtagene Autoleucel was 100%, compared to 53.1% for Ciltacabtagene autoleucel.
These findings suggest that Equecabtagene Autoleucel, a Chinese-developed BCMA CAR-T therapy, offers superior long-term efficacy compared to its U.S. counterpart. As the global community celebrates the first anniversary of its approval, Equecabtagene Autoleucel continues to bring hope to RRMM patients worldwide, further solidifying China’s leading role in the field of cellular therapy.
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp:+8613717959070
Email: doctor.huang@globecancer.com
#ChinaMedicalInnovation #GlobalHealth #MMResearch #PatientCare #InnovativeMedicine #CellTherapy #MedicalBreakthrough
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**A Groundbreaking ADC Drug for Cervical Cancer Approved in China Macau**
**A Groundbreaking ADC Drug for Cervical Cancer Approved in China Macau**
On August 6, 2024, Zai Lab proudly announced the approval of TIVDAK® (tisotumab vedotin-tftv) in Macau, marking the world’s first ADC (antibody-drug conjugate) specifically for cervical cancer. This innovative treatment is intended for patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after chemotherapy.
TIVDAK stands as a significant milestone, being the first ADC drug approved by the FDA for cervical cancer. Following its accelerated approval in 2021, the FDA granted full approval in April 2024, solidifying its use for patients needing treatment after chemotherapy failure.
The FDA’s full approval was backed by positive outcomes from the global Phase 3 clinical trial, innovaTV 301. This study demonstrated that patients treated with TIVDAK experienced an overall survival benefit compared to those receiving chemotherapy. This finding is particularly noteworthy, as TIVDAK is the first ADC drug globally to show clear survival benefits for patients with second and third-line metastatic or recurrent cervical cancer.
Cervical cancer remains a leading threat in women’s health. Despite advancements in prevention through vaccination and early diagnosis via screening, there remains a significant unmet need for effective treatments. In China alone, an estimated 150,000 new cases are diagnosed each year, with approximately 60,000 fatalities. At the time of diagnosis, around 15% of adult patients have metastatic disease. For those diagnosed early and receiving treatment, up to 61% experience recurrence.
Zai Lab is participating in the global innovaTV 301 study and anticipates submitting a marketing application in China by early 2025. This approval in Macau represents a significant step forward in providing new hope for cervical cancer patients worldwide.
🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#CervicalCancer #ADCDrug #TIVDAK #ZaiLab #CancerTreatment #WomenHealth #MedicalAdvancement #FDAApproval #ClinicalTrial #Macau #GlobalHealth #InnovativeTherapy #PatientCare #Pharmaceuticals
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2024 ASCO China Voice: China’s TIL therapy – GC203: A Powerful Strike Against Ovarian Cancer with an 83.3% Disease Control Rate
2024 ASCO China Voice: China’s TIL therapy makes a grand debut, targeting ovarian cancer.
**GC203: A Powerful Strike Against Ovarian Cancer with an 83.3% Disease Control Rate**
Ovarian cancer is a type of gynecologic tumor with a poor prognosis, with 70% of patients being diagnosed at a late stage. Unfortunately, effective treatment options for advanced ovarian cancer are quite limited, primarily relying on platinum-based chemotherapy. However, many ovarian cancer patients are not responsive to chemotherapy. Thus, there is an urgent need for new treatment options.
GC203 (mbIL-7-TIL) is a novel non-viral vector gene-modified TIL therapy utilizing membrane-bound IL-7. Developed by JunSai Biotech using the DeepTIL® cell expansion platform and NovaGMP® gene modification platform, it efficiently modifies T cells in a more economical way, enhancing the antitumor activity of TIL cells, activating internal immune cells, and avoiding systemic toxicity. It does not require lymphodepletion or combined IL-2 therapy post-infusion. A single patient is expected to save approximately 150,000 RMB in associated clinical costs, significantly improving the accessibility of TIL therapy and benefiting more cancer patients.
At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, the latest clinical study results of GC203’s Phase 1 trial (NCT05468307) were announced. Between September 2021 and January 2024, 20 patients with recurrent ovarian cancer were enrolled, having undergone a median of 2.5 lines (range 1-9) of chemotherapy regimens (including PARP inhibitors, immune checkpoint inhibitors, etc.). After enrollment, patients first underwent tumor tissue resection, which was transported to GMP for a 22-26 day preparation period. The cryopreserved infusion products were then returned to the clinical center. Finally, patients received lymphocyte depletion pretreatment (including cyclophosphamide and hydroxychloroquine), a one-time PD-1 antibody infusion, and GC203 TIL cell reinfusion therapy.
After a median follow-up of 8.7 months (range, 2.9-18.8 months), results from 18 evaluable patients showed the following:
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**Objective Response Rate (ORR):** The ORR in evaluable patients (n=18) was 33.3% (95% CI: 16.3%-56.3%). Among them, 22.2% (4 patients) achieved partial response (PR), and 11.1% (2 patients) achieved complete response (CR).
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**Disease Control Rate (DCR):** The DCR in evaluable patients (n=18) was 83.3% (95% CI: 60.8%-94.2%).
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**Median Progression-Free Survival (PFS):** The median PFS was 5.5 months (range, 1.0-14.1 months).
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**Overall Survival (OS) Rate:** The 6-month OS rate was 75.6% (95% CI: 57.4%-99.6%); the 12-month OS rate was 68.8% (95% CI: 49.3%-95.9%).
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**Adverse Reactions:** Most treatment-emergent adverse events (TEAEs) were grade 1 or 2, with common adverse reactions including elevated C-reactive protein levels (33%), fever (33%), and fatigue (11%), which could be alleviated or cured with symptomatic treatment. No other serious adverse reactions were observed.
In summary, for patients with recurrent or metastatic ovarian cancer with limited treatment options, GC203 TIL cell reinfusion therapy has shown good efficacy. Due to low-intensity pretreatment and no need for combined IL-2 therapy, its safety is significantly improved compared to traditional TIL therapy.
**How to Seek Help from TIL Therapy?**
The good news is that several TIL therapy clinical trials are currently recruiting in China, primarily targeting various solid tumors such as non-small cell lung cancer, melanoma, cholangiocarcinoma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, fallopian tube cancer, urothelial cancer, and renal cancer.
Patients seeking help from TIL therapy can submit their complete treatment history, recent pathology reports, imaging examination reports, and discharge summaries to Advanced Medicine in China.
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#OvarianCancer #TILTherapy #CancerTreatment #ASCO2024 #GC203 #Immunotherapy #MedicalResearch #Biotech #Oncology #ClinicalTrials #CancerInnovation #JunSaiBiotech #TIL #CancerBreakthrough #PatientCare #MedicalAdvancements
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China’s another cancer center launches an international medical department, offering comprehensive one-stop medical services to overseas patients
China’s another cancer center launches an international medical department, offering comprehensive one-stop medical services to overseas patients.
The International Medical Department of Tongji Hospital,
The advantages
Furthermore, as another cancer center in China
The medical team
If patients are interested in seeking treatment in China
WhatsApp: +86137 1795 9070
Email: doctor.huang@globecancer.com
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$160,000 per dose! The first approved CAR-T therapy in China, Zevor-cel by CARsgen, announces its initial price for the treatment of multiple myeloma.
🌈 $160,000 per dose! 🌈
⭐The first approved CAR-T therapy in China, Zevor-cel by CARsgen, announces its initial price for the treatment of multiple myeloma.
Zevor-cel
Cheapest CAR-T therapy
US CAR-T
Multiple Myeloma
In China
WhatsApp+8613717959070
doctor.huang@globecancer.com
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Hope For Patients of Gastric Cancer And Pancreatic Cancer – CT041 Typical Cases and Achievements
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Chinese Research Team New Treatment Shows Promise: CD7 CAR-T Cell Therapy for Relapsed/Refractory AML
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Chinese Research: Hopes of CAR-T in Second-Line Treatment of LBCL(Lymphoma)
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.
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.
“If you’d like to inquire about the latest cancer-fighting technologies and treatments, you can contact us.”
whatsapp:+8613717959070
#CARTCellTherapy #CancerTreatment #ScienceInnovation #GeneticMedicine #TumorTreatment #HealthcareTech #MedicalScience #CancerAwareness #PatientCare #FutureOfMedicine