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5 days ago Lymphoma

CAR-T Therapy in China: Relma-cel Offers Deep and Lasting Remission for Patients with Relapsed/Refractory Mantle Cell Lymphoma (MCL)

MCL

#MantleCellLymphoma #MCL #Lymphoma #RRMCL #RelmaCel #CART #Non-HodgkinLymphoma #NHL

In the global cancer treatment landscape, the advancements in CAR-T cell therapy are remarkable, particularly in the treatment of relapsed and refractory Mantle Cell Lymphoma (MCL). China’s CAR-T therapy, Relma-cel, has emerged as a new beacon of hope for patients, delivering deep and lasting remission for those who have undergone multiple lines of treatment.

Mantle Cell Lymphoma: A Complex and Challenging Disease

Mantle Cell Lymphoma (MCL) is a subtype of Non-Hodgkin Lymphoma (NHL) originating from B cells, accounting for 6% to 8% of all NHL cases. The disease typically affects older adults, and most patients are diagnosed at an advanced stage with poor prognostic factors. Despite the availability of various treatments, including Bruton’s Tyrosine Kinase inhibitors (BTKi), MCL remains difficult to cure, and patients often face recurrence or progression of the disease.

Relma-cel: A New Hope for Relapsed/Refractory MCL

In China, Relma-cel, a novel CAR-T cell therapy, was approved by the National Medical Products Administration (NMPA) in August 2024 for the treatment of adult patients with relapsed or refractory MCL who have failed multiple lines of therapy. This therapy offers a groundbreaking treatment option for MCL patients.

A Case Study: Deep Remission Achieved with CAR-T Therapy

A 51-year-old male MCL patient, after multiple treatment failures, eventually achieved complete remission through the CAR-T therapy Relma-cel. Diagnosed in 2014, the patient underwent R-CHOP chemotherapy, Rituximab-targeted therapy, as well as BTKi and PI3K inhibitor treatments. However, the disease continued to relapse with poor prognosis. Finally, in 2022, the patient achieved deep and lasting remission through CAR-T therapy. After CAR-T cell infusion, the patient reached complete remission within just one month and remained in remission for 22 months of follow-up.

Expert Commentary: The Future of CAR-T Therapy

Professor Li Ping from Tongji Hospital, Tongji University, highlighted that CAR-T cell therapy has broken through the limitations of traditional treatments for relapsed/refractory MCL, offering new hope for high-risk patients. For those who cannot benefit from conventional treatments, the introduction of CAR-T therapy is crucial, especially when applied early in the frontline treatment stage to maximize its efficacy.

Based on the latest clinical research data, Relma-cel has shown encouraging complete remission rates (67.8%) and objective response rates (81.36%) in treating relapsed/refractory MCL patients. These findings further underscore the importance of CAR-T cell therapy in patients who have failed BTKi treatment, positioning it as a potential first-choice treatment for these patients.

Globally, CAR-T therapy has become a standard treatment for relapsed/refractory MCL, particularly in third-line treatment settings. For patients with poor prognostic factors, CAR-T therapy may be key to overcoming the limitations of traditional treatments and extending survival.

Conclusion

As CAR-T cell therapy continues to evolve, more patients with relapsed/refractory MCL will have the opportunity to benefit from it. The clinical application of Relma-cel not only brings deep and lasting remission to patients but also sets a new example for the development of CAR-T therapy worldwide. With early intervention and precise treatment strategies, CAR-T therapy has the potential to create a brighter future for MCL patients.

🎉🎉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

（Https://wa.me/+8613717959070）

Email: doctor.huang@globecancer.com

#CAR_T #CancerTreatment #RelmaCel #MCL #LymphomaAwareness #Oncology #Immunotherapy #MedicalInnovation #CancerResearch #ChinaHealthcare

1 week ago Lymphoma

China’s CAR-T Therapy Approved for New Indication: Bringing New Hope to Relapsed Mantle Cell Lymphoma Patients

MCL

The approval of Relmacabtagene Autoleucel brings renewed hope for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL). MCL is a rare and aggressive subtype of non-Hodgkin lymphoma (NHL). Despite advancements in treatment options over recent years, patients with R/R MCL continue to face high relapse rates and poor prognoses. Therefore, there is an urgent need for more effective and innovative therapies to improve treatment outcomes and survival expectations for these patients.

Relmacabtagene, a CD19-targeted autologous CAR-T cell therapy, works by precisely targeting and attacking cancerous B cells. It has shown remarkable efficacy in clinical studies. On August 27, 2024, the National Medical Products Administration (NMPA) officially approved the new indication for Relmacabtagene, allowing its use in adult patients with relapsed or refractory mantle cell lymphoma who have undergone at least two prior systemic therapies, including Bruton tyrosine kinase inhibitors (BTKi). This approval marks another significant milestone following Relmacabtagene’s previous approvals for R/R large B-cell lymphoma (LBCL) and follicular lymphoma (FL).

The treatment of R/R MCL has always been challenging. Traditional therapies often yield limited long-term results, particularly for patients who have failed BTKi treatment, leaving them with fewer options. The emergence of Relmacabtagene offers a new treatment avenue for these patients. Clinical studies demonstrate that this CAR-T cell therapy can significantly extend progression-free survival (PFS) and overall survival (OS), with a favorable safety profile.

The approval of this new indication not only expands the use of Relmacabtagene in treating R/R MCL but also paves the way for future advancements in MCL treatment. The application of CAR-T cell therapy, especially in high-risk patients, has shown potential in overcoming aggressive lymphomas. For patients with complex genetic characteristics and challenging treatment profiles, Relmacabtagene is undoubtedly a powerful therapeutic option.

Looking ahead, Relmacabtagene is expected to benefit more R/R MCL patients in clinical practice, pushing the boundaries of treatment in this field. As research deepens and new therapies continue to emerge, Relmacabtagene is poised to play an increasingly important role in improving patient outcomes and extending survival, offering new hope to R/R MCL patients worldwide.

To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in Chinafor preliminary evaluation!

WhatsApp: +86137 1795 9070

(Http://wa.me/+8613717959070)

Email: doctor.huang@globecancer.com

#BloodCancerTreatment #CAR_TCellTherapy #CancerBreakthrough #Immunotherapy #BCMACART #MedicalAdvancements #CancerSurvivorship #ChinaMedicalInnovation #MCL #RRMCL #HopeForCancerPatients #Relmacabtagene #MCLTreatment #CancerBreakthrough #ChinaApproval #CAR_TCellTherapy #LymphomaTreatment #CancerInnovation #HematologyAdvances

4 weeks ago Lymphoma

Chinese Medical Team Research: 64.6% Complete Remission Rate, Over Half of Patients Progression-Free for More Than Two Years! Targeted Therapy Combined with Chemotherapy is Safe and Effective as First-Line Treatment for Lymphoma

Lymphoma

Peripheral T-cell lymphoma (PTCL) is a group of highly aggressive and heterogeneous diseases with poor prognosis. The standard CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) is widely used as first-line treatment for PTCL. Previous studies have confirmed the safety and efficacy of combining various targeted drugs with CHOP (CHOPX) for PTCL treatment. However, there are multiple PTCL subtypes with different mutations, such as TP53, TET2, KMT2D, and CREBBP/EP300, and evidence is still lacking regarding the effectiveness of these combined treatment regimens in patients with specific genetic mutations.

Recently, a Chinese study published in The Lancet Regional Health–Western Pacific showed that selecting targeted therapies based on specific genetic mutations, combined with CHOP as a first-line treatment for PTCL, demonstrated good efficacy and safety. Compared to standard CHOP, CHOPX treatment achieved a higher complete remission rate and longer progression-free survival. This study was conducted by a Chinese medical team.

This was an open-label, multi-center, non-randomized, external-controlled phase 2 clinical trial (code-named GUIDANCE-03) conducted across seven medical centers in China. The trial compared the efficacy and safety of targeted drug combinations based on specific genetic mutations with CHOP (CHOPX) versus CHOP alone in newly diagnosed PTCL patients.

A total of 96 newly diagnosed PTCL patients (aged ≥18 years, median age 63 years) were enrolled in the study, with 48 patients in each group (CHOPX and CHOP). Genetic sequencing results showed that 93 patients (96.9%) carried genetic mutations. Patients in the CHOPX group received standard CHOP treatment during the first treatment cycle. Starting from the second cycle, targeted drugs were added based on the patient’s specific genetic mutations: decitabine (for TP53 mutations), azacitidine (for TET2/KMT2D mutations), chidamide (for CREBBP/EP300 mutations), and lenalidomide (for patients without these mutations), with a total of six treatment cycles. Patients in the CHOP group received six cycles of CHOP treatment.

The primary endpoint of the study was the complete remission rate (CRR) at the end of treatment. Secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. The analysis results showed:

– At the end of treatment, the CRR of the CHOPX group was superior to that of the CHOP group. Compared to the CHOP group, the CHOPX group saw an approximate 30% improvement in CRR (64.6% vs. 33.3%, OR 0.27, 95% CI 0.12-0.64; P=0.004), achieving the primary endpoint of the study.

– For secondary endpoints, the ORR of the CHOPX group was better than that of the CHOP group (66.7% vs. 52.1%).

– During a median follow-up period of 24.3 months, the median PFS of the CHOPX group was significantly longer than that of the CHOP group (25.5 months vs. 9.0 months; HR 0.57, 95% CI 0.34-0.98; P=0.041), with a 43% reduction in the risk of disease progression or death. The 2-year PFS rates for the two groups were 53.2% (95% CI 38.7-67.7) and 28.0% (95% CI 13.6-42.3), respectively.

In terms of OS, the median OS for the CHOPX group has not yet been reached, while the median OS for the CHOP group was 30.9 months. The CHOPX group showed a trend toward improved OS, but the current statistical results are not significant (HR 0.55, 95% CI 0.28-1.10; P=0.088). The 2-year OS rates for the two groups were 68.0% and 60.8%, respectively.

Regarding safety, neutropenia was the most common adverse event in both the CHOPX and CHOP groups (82% in the CHOPX group and 73% in the CHOP group). The most common grade 3-4 hematologic adverse event in both groups was neutropenia, and the most common grade 3-4 non-hematologic adverse event was infection. In the CHOPX group, 65% (31 patients) reported neutropenia, but no patients experienced prolonged neutropenia (>14 days) or required dose adjustments of the targeted drugs, and 10% (5 patients) experienced infections. In the CHOP group, these proportions were 52% (25 patients) and 4% (2 patients), respectively.

In conclusion, the study results indicate that different targeted drugs combined with CHOP demonstrate good efficacy and safety. These findings provide preliminary evidence supporting the use of CHOPX as a first-line treatment for PTCL patients with different genetic mutations, and suggest that biomarker-driven treatment strategies are feasible and worth further exploration in the future.

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

#CancerResearch #LymphomaTreatment #PTCL #TargetedTherapy #Chemotherapy #MedicalBreakthrough #Oncology #ClinicalTrials #ChineseMedicine #CancerSurvivorship #HealthcareInnovation #PrecisionMedicine #CancerTreatment #MedicalResearch #CHOPTherapy #OncologyUpdates #CancerCare

1 month ago Hematological Neoplasms

Blood Cancer Solution Including leukemia, lymphoma, multiple myeloma, and others.

Blood Cancer Solution

Including leukemia, lymphoma, multiple myeloma, and others.

Blood Cancer

#leukemia #lymphoma #multiplemyeloma

#Hematologic malignancies are a group of malignant diseases originating from hematopoietic cells, often affecting the bone marrow, blood, and various organs and tissues throughout the body. Common types of hematologic malignancies include leukemia, myelodysplastic syndromes, lymphomas, multiple myeloma, and myeloproliferative neoplasms.

The causes of these diseases are complex, involving genetic mutations, immune abnormalities, radiation exposure, contact with harmful chemicals, infections, and hereditary factors. Additionally, poor lifestyle habits, high levels of stress, and environmental factors can also increase the risk of developing these conditions.

With an aging population and advancements in medical technology, the incidence of hematologic malignancies has been rising globally. In China, the incidence and mortality rates of leukemia and lymphoma are now among the top ranks of all malignancies.

However, hematologic malignancies are not incurable. In recent years, the treatment methods for these diseases have seen significant progress. From traditional combination chemotherapy and radiotherapy to hematopoietic stem cell transplantation, monoclonal antibody therapy, antibody-drug conjugates, small molecule targeted therapies, and the latest immunotherapies, treatment options have become increasingly diverse and precise.

Combination chemotherapy remains a primary treatment for many hematologic malignancies, despite its significant side effects. The efficacy of these treatments cannot be ignored. Modern chemotherapy regimens are continually being refined, including the incorporation of new cytotoxic drugs and targeted therapies, as well as the use of monoclonal antibodies. Additionally, the appropriate use of antiemetics, hematopoietic growth factors, and anti-infective agents helps to mitigate adverse effects.

Hematopoietic stem cell transplantation continues to be one of the most effective treatments for certain hematologic malignancies. The development of this treatment in China has been rapid, with 170 registered transplant centers by 2020.

Monoclonal antibodies, often referred to as “biological missiles,” have a high degree of specificity and single biological activity. They have revolutionized the treatment of hematologic malignancies. Antibody-drug conjugates (ADCs) utilize monoclonal antibodies to accurately identify tumor cell markers, guiding the delivery of chemotherapy drugs for targeted treatment.

Small molecule targeted therapies work by interfering with specific genes or proteins to inhibit tumor cell growth and proliferation. Gleevec, the first small molecule targeted therapy, increased the five-year survival rate for chronic myeloid leukemia (CML) patients from 30% to 89%, marking a breakthrough in cancer treatment. Today, there are numerous small molecule targeted drugs available for the treatment of hematologic malignancies, including BCR-ABL inhibitors, BTK inhibitors, BCL-2 inhibitors, PI3K inhibitors, and XPO1 inhibitors, with many more drugs currently in clinical trials expected to become available soon.

Immunotherapy includes immune checkpoint inhibitors (such as PD-1/L1), cancer vaccines, cellular immunotherapies (such as #CART), and nonspecific immunomodulatory treatments. #CARTtherapy, in particular, has gained widespread attention as an emerging curative treatment. This approach involves extracting a patient’s T cells, modifying them outside the body to specifically recognize and attack tumor cells, and then reinfusing the modified T cells into the patient. This therapy has been successfully applied to various hematologic malignancies, including acute lymphoblastic leukemia, lymphomas, and multiple myeloma. The first patient treated with CAR-T therapy has been disease-free for 11 years.

In recent years, China has made significant advances in the treatment of hematologic malignancies. The establishment of the “Chinese Expert Consensus on the Diagnosis and Treatment of High-Risk Multiple Myeloma” and the presentation by Professor Huang He at the 2024 #EHA conference on targeting CD7 universal CAR-T therapy for T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) have shown remarkable efficacy and safety. Additionally, exciting new data from the 2024 American Society of Clinical Oncology (#ASCO) annual meeting highlighted the efficacy of Relma-cel in treating relapsed/refractory large B-cell lymphoma (R/R LBCL), with a four-year overall survival rate (#OS) of 66.7%. Particularly noteworthy is the research on multiple myeloma, where the BCMA-targeted CAR-T therapy has demonstrated deep and lasting responses, with a complete response (#CR) rate of 82.4% and a 12-month progression-free survival (#PFS) rate of 85.5%.

With the continuous development of new treatments and the emergence of new drugs, hematologic malignancies in China are no longer considered incurable diseases. Through standardized, individualized, and precise treatments, many patients with hematologic malignancies can achieve long-term disease-free survival, and even a cure, returning to normal work and life. As medicine continues to advance, every life will continue to shine brightly!

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

#HematologicMalignancies #LeukemiaAwareness #LymphomaResearch #MultipleMyeloma #BloodCancer #CancerResearch #CAR_Therapy #StemCellTransplant #Immunotherapy #TargetedTherapy #MonoclonalAntibodies #CancerTreatment #MedicalAdvancements #CancerSurvivor #HealthcareInnovation

1 month ago Lymphoma

2024 ASCO | Relma-cel Achieves a 4-Year OS Rate of 66.7% in Treating R/R LBCL, Making Lymphoma Cure Possible

Lymphoma

Over the past few decades, there have been significant advancements in the treatment of hematologic malignancies, particularly with CAR-T cell therapy. Recently, Relma-cel (relmacabtagene autoleucel) showcased promising new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting its remarkable efficacy in treating relapsed/refractory large B-cell lymphoma (R/R LBCL).

### Breakthrough in CAR-T Therapy

Relma-cel is a CD19-targeted CAR-T cell therapy that reprograms a patient’s own T cells to recognize and attack cancer cells. Studies have shown that Relma-cel achieves a 4-year overall survival (OS) rate of 66.7% in patients with R/R LBCL, with the rate soaring to 82.5% for those who achieve complete remission (CR). These results indicate that Relma-cel not only significantly extends survival but also increases the cure rate for these patients.

### The Power of Long-Term Follow-Up Data

The RELIANCE study, one of the largest CAR-T cell therapy studies in China, aims to evaluate the efficacy and safety of Relma-cel in R/R LBCL patients. The latest 4-year follow-up data reveals that 25 patients remain alive, and the median overall survival (OS) has not yet been reached. This milestone offers immense hope for patients and physicians, underscoring the long-term survival benefits of this therapy.

### Balancing Safety and Efficacy

Relma-cel also excels in safety. The incidence rates of ≥3 grade cytokine release syndrome (CRS) and neurotoxicity (NT) are 5.1% and 3.4%, respectively. Compared to other CD19 CAR-T cell therapies, Relma-cel effectively reduces side effects while significantly enhancing efficacy. This success is largely attributed to its unique CAR structure design, which includes a 4-1BB costimulatory domain, a CD28 transmembrane domain, and an optimized hinge region. These features enable Relma-cel to survive longer in the body and enhance its tumor-killing power.

### Future Prospects

As Relma-cel continues to expand its reach, more R/R LBCL patients are expected to benefit from this advanced treatment. Currently, Relma-cel is exploring its potential use in second-line treatment for LBCL and frontline therapy for high-risk LBCL patients. Additionally, it has shown excellent clinical value in treating relapsed/refractory follicular lymphoma (R/R FL) and mantle cell lymphoma (R/R MCL).

Relma-cel’s success not only brings new hope to lymphoma patients but also signifies a new era in the treatment of hematologic malignancies. We look forward to more research findings on Relma-cel, which will bring hope and possibilities for curing lymphoma to patients worldwide.

With Relma-cel, curing lymphoma is no longer an unattainable dream. Let’s anticipate more breakthroughs in this field, bringing new light to the lives of every patient.

🎉🎉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

#LymphomaTreatment #CAR_TTherapy #CancerResearch #RelmaCel #HopeForPatients #MedicalAdvancements #ASCO2024 #InnovativeTherapies #Survivorship #CureLymphoma

1 month ago Lymphoma

Chinese Medical Team: Sequential CD20 CAR-T Therapy Outperforms Salvage Chemotherapy for CD19 CAR-T Resistant B-Cell Lymphoma Patients

## Chinese Medical Team: Sequential CD20 CAR-T Therapy Outperforms Salvage Chemotherapy for CD19 CAR-T Resistant B-Cell Lymphoma Patients

CAR-T therapy

In recent years, with the application of CD19 CAR-T in refractory/relapsed B-cell lymphoma, we have encountered patients for whom CD19 CAR-T therapy was ineffective or who relapsed shortly after initial success. While research continues to explore factors that may affect the efficacy of CD19 CAR-T therapy, doctors and scholars are actively seeking more effective treatments for these patients. In June of this year, Professor Ke Xiaoyan and Professor Hu Kai from the Lymphoma and Myeloma Department of Beijing Gaobo Hospital published an article titled “Salvage CD20-SD-CART Therapy in Aggressive B-Cell Lymphoma After CD19 CART Treatment Failure” in the journal Frontiers in Oncology. This study provides new insights for treating B-cell lymphoma patients who have failed CD19 CAR-T therapy.

### Efficacy of Sequential CD20 CAR-T Therapy Exceeds Salvage Chemotherapy Post-CD19 CAR-T Failure

Regarding the innovation of this research, Professor Hu Kai pointed out that international scholars currently focus on chemotherapy (including new drugs), targeted drug therapy, and allogeneic hematopoietic stem cell transplantation for B-cell lymphoma patients who have failed CD19 CAR-T therapy. However, there is limited data on switching targets for a second CAR-T therapy. Our team summarized the treatment outcomes of 93 B-cell lymphoma patients who failed CD19 CAR-T therapy. Among them, 54 out of 93 (58%) chose sequential CD20-targeted second CAR-T therapy, and 39 out of 93 (42%) opted for chemotherapy combined with new drugs and targeted therapy. The results showed that the complete remission rate (CRR) in the sequential CD20 CAR-T group was significantly higher than in the chemotherapy group, with rates of 27.8% and 7.9%, respectively (P=0.03).

After a median follow-up period of 18.54 months, the sequential CD20 CAR-T group showed a significantly longer median progression-free survival (4.04 months vs. 2.27 months, P=0.0032) and median overall survival (8.15 months vs. 3.02 months, P<0.0001) compared to the non-CAR-T group. Multivariate analysis further confirmed that sequential CD20-targeted second CAR-T therapy is an independent factor associated with improved overall survival (HR 0.28, 95%CI: 0.16-0.51; P<0.0001) and progression-free survival (HR 0.46, 95%CI: 0.27-0.8; P=0.005).

### Safety of Sequential CD20-Targeted Second CAR-T Therapy

The study noted that the incidence of severe CRS (≥ grade 3) and ICANS (≥ grade 3) was relatively low during the sequential CD20-targeted second CAR-T therapy, at 9.2% and 7.4%, respectively, with complete recovery after treatment. Other adverse reactions were also controllable.

### Factors Affecting the Efficacy of Second CAR-T Therapy

We used a univariate regression model to evaluate factors affecting the response to sequential CD20-targeted second CAR-T therapy. An IPI score of ≥3 (OR 0.3, 95%CI: 0.10-0.93, P=0.04) was significantly associated with a lower overall response rate (ORR). Additionally, ECOG PS ≥3 (HR 3.12, 95%CI: 1.23-7.94, P=0.02) was associated with decreased progression-free survival and overall survival.

### Study Commentary

Professor Ke Xiaoyan highlighted that the Lymphoma and Myeloma Department at Beijing Gaobo Hospital has accumulated extensive experience with CAR-T therapy in recent years. As the number of CAR-T cases increases in real-world scenarios, CD19 CAR-T may cure half of the patients with relapsed/refractory B-cell lymphoma. For patients who fail CD19 CAR-T therapy, clinical problems become more complex. Our experience suggests that selecting CD20-targeted second CAR-T therapy based on the expression of surface antigens on recurrent tumors can still achieve better results than salvage chemotherapy, extend patient survival, and maintain controllable safety. Tumor burden and the patient’s physical condition remain factors affecting the efficacy of sequential CD20 CAR-T 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

#CAR-T #CancerTreatment #LymphomaResearch #MedicalAdvancements #CD19CAR-T #CD20CAR-T #Oncology #ClinicalResearch #CancerSurvivorship #MedicalBreakthroughs

2 months ago Lymphoma

China’s Breakthrough in CAR-T Therapy for CNS Lymphoma

### China’s Breakthrough in CAR-T Therapy for CNS Lymphoma

Lymphoma

In a pioneering effort to improve outcomes for patients with refractory/relapsed central nervous system lymphoma (CNSL), a multi-center retrospective study led by Professor Jianqing Mi from Ruijin Hospital, Shanghai Jiaotong University School of Medicine, has showcased the impressive real-world effectiveness of Relmacabtagene Autoleucel (Relma-cel). This study, encompassing data from 12 centers across China, represents the largest sample size for a real-world study on commercial CAR-T therapy in treating CNSL, and its results have been recently published in the Journal for ImmunoTherapy of Cancer.

### Study Overview and Patient Demographics

The study included 22 patients aged 18 and above, all diagnosed with CD19+ refractory or relapsed CNSL. These patients had previously undergone various systemic treatments, including CD20 monoclonal antibody immunochemotherapy and high-dose methotrexate-based therapies. Of the participants, 12 had primary CNSL and 10 had secondary CNSL. The median age was 56, with 45.5% being over 60 years old. The study focused on a high-risk group, with many having a Karnofsky Performance Status (KPS) score of ≤60, multiple prior treatment lines, and/or high-risk genetic profiles such as double-hit lymphoma (DHL).

### Treatment and Response

Patients received Relma-cel with a median interval of 32 days between apheresis and infusion. Thirteen patients received a single CAR-T cell infusion, while nine underwent autologous stem cell transplantation (ASCT) in combination with CAR-T infusion. Notably, 20 patients received bridging therapy to control disease before CAR-T infusion. The overall response rate (ORR) was 90.9%, with a complete response (CR) rate of 68.2%. Impressively, all patients achieved CNS response, with 72.7% achieving CNS CR. The median time to response was one month.

### Follow-Up and Survival Outcomes

The median follow-up period was 316 days. Among the 16 patients who achieved CNS response, 81.3% remained alive and in remission, with half maintaining CNS CR for over a year. The study reported a one-year progression-free survival (PFS) rate of 64.4%, duration of response (DOR) rate of 71.5%, and overall survival (OS) rate of 79.2%. Key predictors of better outcomes included achieving CR before infusion and having non-progressive disease at the time of infusion.

### Safety and Tolerability

The safety profile of Relma-cel was acceptable. Cytokine release syndrome (CRS) occurred in 72.7% of patients, primarily grade 1 or 2, with only one case of grade 3. Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 36.4% of patients, mostly grade 1 or 2. There were no CAR-T therapy-related deaths, although five patients (22.7%) died, with three deaths due to disease progression and two from non-relapse causes (COVID-19).

### CAR-T Cell Dynamics and Combined Therapy

The study also explored the pharmacokinetics of CAR-T cells. Relma-cel showed significant expansion in the peripheral blood within the first 28 days post-infusion, with CAR-T cells detected in the cerebrospinal fluid of all evaluable patients. Interestingly, patients receiving additional immunotherapies like BTK inhibitors or PD-1 inhibitors exhibited CAR-T cell re-expansion, suggesting potential synergistic effects.

### Conclusion and Future Directions

This landmark study underscores the clinical efficacy and manageable safety profile of Relma-cel for treating CNSL in a real-world setting. It highlights the potential benefits of combining CAR-T therapy with other immunotherapies, offering a promising strategy for enhancing CAR-T cell persistence and effectiveness. These findings pave the way for future research, suggesting the need for larger, randomized studies to further validate these results and explore the role of CAR-T therapy as a consolidation treatment for high-risk CNSL patients. As China continues to advance in medical research and technology, studies like this are crucial in providing valuable insights and improving global healthcare standards.

🎉🎉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

#CARTTherapy #CNSLymphoma #CancerResearch #MedicalBreakthrough #ChinaHealthcare #Immunotherapy #RelmaCel #PatientOutcomes #InnovativeTreatment #ClinicalStudy

3 months ago Lymphoma , CAR-T

Participants in China’s CAR-T ‘Lymphoma Value-Based Payment Plan’ have achieved complete remission

🎗️ Participants in China’s CAR-T ‘Lymphoma Value-Based Payment Plan’ have achieved complete remission. 🎗️

Lymphoma

Exciting news! Fosun Kite has just announced that the first participants in China’s “Lymphoma Value-Based Payment Plan” have achieved complete remission. These four patients, hailing from Shanghai, Guangzhou, and Hangzhou, have all reached complete remission after undergoing the innovative CAR-T cell immunotherapy, bringing new hope to lymphoma treatment.

### Why is CAR-T Therapy So Important?

Lymphoma is a malignant tumor originating from the lymphatic hematopoietic system, with diffuse large B-cell lymphoma being the most common type. For many patients, traditional treatment methods may be limited, especially for those with refractory or early-relapsed disease. The advent of CAR-T cell therapy offers these patients a new treatment option.

### Innovative Payment Model: Value-Based Payment

Fosun Kite’s “Value-Based Payment Plan” is a groundbreaking initiative. Eligible patients who do not achieve complete remission after treatment can receive up to 600,000 RMB in financial reimbursement. This payment model not only alleviates the financial burden on patients but also ensures the effectiveness and value of the treatment.

### Success Stories from Initial Participants

At the First Affiliated Hospital of Zhejiang University School of Medicine, one of the initial participants achieved complete remission after receiving CAR-T therapy. Deputy Director Hu Yongxian explains that when lymphoma cells can no longer be detected in the patient’s body, it signifies complete remission (CR), which is crucial for long-term survival and cure.

### Future Prospects

Professor Zhu Zhigang believes this innovative payment model can benefit more patients and potentially facilitate the inclusion of CAR-T therapy in national health insurance, further enhancing medical accessibility. In the future, we hope to see more patients gain new life through this advanced treatment.

### Conclusion

The emergence of CAR-T cell therapy and the introduction of the “Value-Based Payment Plan” bring unprecedented hope to lymphoma patients. This is not only a breakthrough in medical technology but also an innovation in medical payment models. Let’s look forward to more patients benefiting from this advanced treatment and embarking on the path to recovery.

🎉🎉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

#Health #CancerTreatment #InnovativeTherapy #CART #FosunKite #Lymphoma #MedicalInnovation #CompleteRemission

5 months ago CAR-T

China’s First CAR-T Trial: “Pay-for-Performance” Introduced!

CAR-T

China has taken a groundbreaking step towards pay-for-performance! Fosun Kite announces an exciting initiative: the ¥1.2 million(RMB) #CARTcell therapy will now be paid based on its effectiveness!

NO CR – Refund

This means that eligible patients using Fosun Kite’s #CARTtherapy, #Axicabtagene Ciloleucel, will undergo effectiveness assessment three months after drug purchase and infusion. If complete remission (CR) is not achieved, patients will receive a refund of up to ¥600,000(RMB)!

This innovative payment model

is not only China’s first for lymphoma drugs but also the country’s first for bio-innovative drugs!

#CARTcelltherapy

is an immunotherapy method that involves genetically modifying a patient’s T cells outside the body to recognize specific tumor targets before reinfusing them to precisely combat #tumors. Currently, five products, including Fosun Kite’s #AxicabtageneCiloleucel, have been approved domestically.

As a form of immunotherapy, CAR-T cell therapy works by collecting a patient’s T cells and genetically modifying them outside the body to recognize specific tumor targets. These modified T cells are then reintroduced into the patient, enabling precise targeting and attacking of tumors. Currently, there are five approved products domestically, including Axicabtagene Ciloleucel from Fosun Kite, Relmacabtagene Autoleucel from JW Therapeutics, Equecabtagene Autoleucel from IASO Bio, Inaticabtagene Autoleucel from Juventas, and Zevorcabtagene autoleucel from CARsgen.

New Hope

Unlike traditional drugs, CAR-T requires individualized production for each patient, thus incurring higher costs. However, this innovative pay-for-performance model brings new hope to patients!

“Cure” standards

Fosun Kite’s project leader stated that they will collaborate with clinical experts, health commissions, treatment demonstration centers, and other stakeholders to establish “Cure” standards, objectively assessing lymphoma efficacy. This will provide reliable evaluation criteria for performance-based payment!

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

#CART #PayForPerformance #Lymphoma #BioInnovativeDrugs #InnovativePaymentModel #Immunotherapy #MedicalInnovation #TechnologicalAdvancement #MedicalProgress #FosunKite #ChineseHealthcare

6 months ago

Shanghai Hospital Achieves Complete Remission and Discharge of the 100th Patient with Relapsed/Refractory Lymphoma Treated with CAR-T Therapy

Lymphoma

Ruijin Hospital,

affiliated with Shanghai Jiao Tong University School of Medicine, announced that with continuous exploration in clinical practice, experts have made progress in CAR-T cell therapy for lymphoma, benefiting an increasing number of patients. This advancement is of significant importance for further promoting and expanding the application of CAR-T therapy, allowing more patients to benefit from it.

Lymphoma

is a malignant tumor originating from the lymphatic hematopoietic system and encompasses a family of nearly a hundred different subtypes. Relapse and drug resistance pose major challenges for patients. CAR-T products have the potential to improve treatment outcomes and facilitate the broader application of CAR-T therapy among a wider range of patients in China.

CAR-T therapy

involves genetically modifying T cells to equip them with the ability to recognize tumors, enabling them to kill cancer cells in the body. If natural T cells can be likened to “ordinary soldiers,” then CAR-T cells can be considered as “special forces.” For cancer patients, the 5-year survival rate is an important milestone and a signal of cancer being cured. Achieving a 5-year survival implies that some cancer patients treated with CAR-T therapy can obtain long-term survival without further anticancer drug treatment, truly achieving the possibility of “cancer being cured.” Aunt Qin, the first patient enrolled in China’s CAR-T registered clinical trial in 2018, has achieved sustained complete remission for over 5 years and is about to enter the 6th year.

100th patient

At Ruijin Hospital, the 100th patient with relapsed/refractory lymphoma treated with CAR-T therapy has achieved complete remission and been discharged. The patient, Ms. Xu (alias), is a 41-year-old woman who now has a healthy complexion. She was initially diagnosed with follicular lymphoma and underwent chemotherapy and targeted therapy. However, the disease relapsed three months later, transforming into high-grade B-cell lymphoma. High-grade B-cell lymphoma is highly malignant with a poor prognosis. Professor Zhao Weili from the Hematology Department at Ruijin Hospital conducted a detailed analysis of Ms. Xu’s condition and developed a treatment plan for her. On November 22, 2023, after receiving CAR-T cell infusion, Ms. Xu showed complete remission of the tumor during the follow-up examinations at one month and three months.

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!

You can send electronic copies or photos of genetic testing reports and diagnostic reports to:

Email: doctor.huang@globecancer.com

or WhatsApp+8613717959070

The Medical Department will contact you as soon as receive the reports.

#CARTtherapy #LymphomaTreatment #CompleteRemission #RuijinHospital #MedicalAdvancements #CancerResearch #CARTProgress #HopeForPatients #SurvivingLymphoma #HealthcareInnovation #PatientStories #CancerCure #CARTSuccess #MedicalBreakthrough #ImprovingOutcomes #LymphomaAwareness #FightAgainstCancer #CARTJourney #MedicalMilestone #LongTermSurvival #BeatingCancer #lymphoma #cancerawareness

7 months ago CAR-T

Miracle Unfolds: Zhejiang University Hospital’s Custom CRISPR/Cas9 Gene Editing + CAR-T Cell Therapy Rebirths Patients

🌟 Miracle Unfolds: Zhejiang University Hospital’s Custom CRISPR/Cas9 Gene Editing + CAR-T Cell Therapy Rebirths Patients 🌟

👨‍👧‍👦 (“I want to live to see my child go to university!”)👨‍👧‍👦

CAR-T Cell Therapy Patient

🎓 This heartfelt cry came from Mr. Sun, a 40-year-old patient from Guangzhou, who faced the formidable challenge of diffuse large B-cell lymphoma, a common adult lymphoma type.

🔬14 rounds of chemotherapy, 20 rounds of radiotherapy, total gastrectomy… For two years,

Mr. Sun sought treatment nationwide, endured endless suffering, yet couldn’t defeat the chameleon of the tumor world – diffuse large B-cell lymphoma.

“It’s tough. Prepare yourself mentally.” “I want to live to see my child go to university.”

🍋Seeking a glimmer of hope, he turned to Zhejiang University Hospital in Hangzhou. This time, the doctors said, “Let’s give it a try together.”

Multiple abdominal lymphoma lesions invading the intestinal wall, multiple rounds of chemo couldn’t stop the lymphoma from spreading everywhere. Intestinal wall invasion by lymphoma is a relative contraindication for CAR-T therapy, as it can lead to intestinal perforation, so he was no longer suitable for traditional CAR-T cell therapy.

🌿Prof. Liu Mingyao’s team and Prof. Huang He’s team used the Nobel Prize-winning CRISPR/Cas9 gene editing technology to precisely knock out the PD1 site in T lymphocytes and insert the targeted CD19 CAR molecule for tumor cells, creating a brand-new non-viral targeted integrated CAR-T cell (PD1-19bbz), and successfully completed Phase I clinical trials in humans for the first time, verifying the safety and efficacy of the new CAR-T cells.

💪The brand-new PD1-19bbz CAR-T cells, with a low risk of cytokine storms and other complications, gave Mr. Sun a new lease on life.

👑Mr. Sun received PD1-19bbz CAR-T cell infusion and returned. Fourteen days after CAR-T cell return, all indicators were normal. After evaluation, he was discharged. One month after the return, PET-CT evaluation showed that the large mass of tumor invading the intestinal mucosa in the original abdominal cavity had completely disappeared.

🏸Today, Mr. Sun has been disease-free for over 2 years.

In a recent follow-up, all of Sun’s examination results were normal, his weight had increased significantly compared to before his illness, and his complexion looked much healthier. “After cell therapy, my body suddenly felt normal again. My friends and family all say I’ve miraculously recovered. Now in my spare time, I even play badminton, completely restoring my pre-illness lifestyle.”

Tsinghua University

🎨Two years later, in the summer of 2022, Mr. Sun shared good news with the medical staff in Hangzhou: his child has been accepted to the School of Arts at Tsinghua University!

🎉To assess whether the condition is suitable for CAR-T therapy, you can submit Advanced Medicine in China for preliminary evaluation!

Email: doctor.huang@globecancer.com,

WhatsApp: +8613717959070

🌿 #MiracleRebirth #CRISPR #CARTCellTherapy #ZhejiangUniversity #TsinghuaUniversity #MedicalBreakthroughs #CancerTreatment

8 months ago CAR-T

Lyn’s Triumph Over Lymphoma: A CAR-T Journey in Shanghai

🌈🌈Lyn’s Triumph Over Lymphoma: A CAR-T Journey in Shanghai! 🌟🌟 #CARTVictory

⚡️⚡️Lyn, a mother of three from Singapore, faced unexpected health challenges in 2022. She experienced persistent pain in her shoulders, neck, and upper limbs, disrupting her sleep and even affecting her ability to breathe. A visit to the emergency department at Shanghai Jiahui International Hospital revealed a shocking discovery – a massive tumor in her mediastinum, measuring 15 cm in diameter! The compression from this large mass not only caused excruciating pain but also impacted nearby organs such as the heart, major blood vessels, and lungs, leading to Superior Vena Cava Syndrome (SVCS). Lyn struggled with breathing difficulties, posing an imminent threat to her life.

🌸🌸The diagnosis pointed to “Primary Mediastinal Large B-cell Lymphoma,” a relatively uncommon subtype of lymphoma, prevalent among young individuals, particularly females. Despite undergoing various comprehensive treatments, including chemotherapy combined with targeted therapy and consolidative radiotherapy, Lyn unfortunately showed no response to these treatments. Eventually, the decision was made to pursue CAR-T cell therapy.

🧶🧶Lyn’s husband emphasized, “The cost of CAR-T treatment abroad is significantly higher than in China, and the waiting period is at least 3-6 months. We trust the medical expertise of China and Shanghai Jiahui. Their professionalism and meticulous care left a deep impression on us. Our decision was absolutely correct.”

💥💥 The treatment team at Shanghai Jiahui International Hospital, led by Director Vicky H. Lee and Dr. Lili Zhou, the head of the Hematology and Oncology Department, developed a meticulous treatment plan to navigate Lyn through the entire CAR-T therapy. They highlighted the critical importance of two stages: the period from cell collection to pre-infusion and the phase post-infusion, which poses a risk of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

🍁🍁 After careful preliminary treatments, infection screening, and confirmation through cell collection, Lyn received the CAR-T cell infusion. Following infusion, the “T-cell soldiers” proliferated successfully in her body, providing relief from tumor-related pain. Upon clinical assessment confirming stable conditions, Lyn smoothly transitioned to being discharged.

⛵️⛵️ It’s worth noting that CAR-T therapy costs comprise drug and non-drug expenses, with the overall treatment expenses significantly lower in China compared to Western countries. Shanghai Jiahui International Hospital collaborates with local high-quality medical resources such as Ruijin Hospital and Tongji Hospital, offering patients a comprehensive one-stop CAR-T diagnostic and therapeutic service.

#CART #SurvivorStories #MedicalMiracle #Inspiration #JiahuiInternationalHospital #CancerSurvivor #CARTTherapy #HealthJourney #advancedmedicineinchina #chinesemedicine

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