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1 week ago Myeloma , CAR-T

China’s Fully Human BCMA CAR-T Therapy: Bringing New Hope for High-Risk Relapsed/Refractory Multiple Myeloma

Mutiple Myeloma

Multiple Myeloma (MM) is a complex and aggressive cancer originating from plasma cells, posing significant treatment challenges due to its resistance to therapy. For patients with high-risk MM, especially those who experience relapse after multiple lines of treatment, finding an effective therapy is critical. Recently, Chinese medical team successfully treated a case of high-risk relapsed/refractory MM (RRMM) using fully human BCMA CAR-T cell therapy, offering new hope for such difficult cases.

Case Overview

The patient, a 56-year-old woman, presented with anemia during a routine check-up and was later diagnosed with MM. Despite undergoing several treatment regimens, including VRd (bortezomib, lenalidomide, dexamethasone) and Dara-DECP followed by autologous stem cell transplantation (ASCT), the disease continued to progress, with extramedullary disease (EMD) manifestations complicating the case.

Challenges and Treatment Journey

After initial treatments failed to achieve long-term remission, the patient’s condition worsened, with new lesions detected in the pancreas and multiple subcutaneous nodules indicating possible metastasis. Given the aggressive nature of the disease and the presence of EMD, which is associated with a poor prognosis, the medical team opted for a BCMA-targeted CAR-T cell therapy using Iquarense (Ikaros CAR-T), the first CAR-T product approved for MM treatment in China.

CAR-T Therapy and Results

Following pre-conditioning with a fludarabine-cyclophosphamide (FC) regimen, the patient received the BCMA CAR-T therapy. The treatment was well-tolerated, with only mild cytokine release syndrome (CRS) observed. Remarkably, within three months post-treatment, PET-CT scans showed no signs of active disease, and the patient achieved a complete response (CR), which has been sustained for eight months.

Significance and Future Implications

This case highlights the potential of BCMA CAR-T therapy as a powerful option for patients with high-risk, relapsed/refractory MM, particularly those with EMD. The successful outcome not only provides new hope for patients facing similar challenges but also contributes valuable insights for future treatment strategies. Iquarense, with its low immunogenicity and prolonged persistence in the body, represents a promising advance in the fight against this formidable disease.

For patients with high-risk MM, it is crucial to consider genetic factors, treatment response, and overall disease dynamics when selecting a therapeutic approach. As this case demonstrates, BCMA CAR-T therapy offers a viable path forward, particularly for those with limited options due to disease progression or EMD.

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

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

Email: doctor.huang@globecancer.com

#BloodCancerTreatment #CAR_TCellTherapy #CancerBreakthrough #Immunotherapy #BCMACART #MedicalAdvancements #CancerSurvivorship #ChinaMedicalInnovation #HopeForCancerPatients

3 weeks ago Myeloma

Groundbreaking Results for Chinese CAR-T Therapy: 86% Response Rate of BCMA/GPRC5D Dual-Target Treatment Multiple myeloma

Groundbreaking Results for Chinese CAR-T Therapy: 86% Response Rate of BCMA/GPRC5D Dual-Target Treatment

Multiple myeloma

#MultipleMyeloma #ChineseCART #BCMA #GPRC5D #DualTarget #MM #RRMM

Multiple myeloma (MM) is a challenging blood cancer, particularly in relapsed/refractory (R/R) cases. While therapies like proteasome inhibitors, immunomodulators, CD38 monoclonal antibodies, and stem cell transplants have improved outcomes for newly diagnosed patients, treatment-resistant forms of MM remain a serious concern. A new therapeutic approach combining two targets, BCMA and GPRC5D, may provide a breakthrough solution.

BCMA has long been a key target for treating R/R MM due to its expression in malignant plasma cells. However, BCMA-targeted therapies face limitations, including tumor cells losing or downregulating BCMA, leading to disease recurrence. This is where GPRC5D, a protein highly expressed in MM cells and linked to poor prognosis, comes in. By targeting both BCMA and GPRC5D, researchers aim to overcome the limitations of single-target therapies.

A collaboration between a leading Chinese hospital and research institutions has now delivered promising results. A Phase I clinical trial involving 21 patients with R/R MM using the dual-target BCMA/GPRC5D CAR-T cell therapy reported an overall response rate (ORR) of 86%, with 75% of patients achieving a complete response (CR). Notably, even patients whose cancer cells lacked BCMA or GPRC5D expression showed significant improvement, underscoring the versatility of this treatment.

Key Results from the Study:

– 21 patients with advanced, heavily pre-treated R/R MM participated.

– Of the 12 patients who received the optimal dosage of 2.0×10⁶ CAR-T cells/kg, 86% showed clinical response, with 75% achieving complete remission.

– Importantly, patients with BCMA or GPRC5D-negative cancer cells also responded well to treatment.

– The treatment was well-tolerated, with manageable side effects, including 71% of patients experiencing mild to moderate cytokine release syndrome (CRS).

This trial, published in The Lancet Haematology, represents a major step forward in MM treatment. The dual-target approach addresses the limitations of BCMA-targeted therapies, offering new hope to patients who have exhausted conventional options.

Looking ahead, this innovative therapy could reshape the future of multiple myeloma treatment, offering a powerful new tool in the fight against this complex disease.

🎉🎉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 #MultipleMyeloma #CAR_TTherapy #MedicalInnovation #OncologyBreakthrough

1 month ago Myeloma

Overcoming Challenges and Embracing New Life! – Breakthrough Progress of Eque-cel in the Treatment of Refractory Multiple Myeloma

### Overcoming Challenges and Embracing New Life! – Breakthrough Progress of Eque-cel in the Treatment of Refractory Multiple Myeloma

Multiple Myeloma

In the treatment of multiple myeloma (MM), how do we find new breakthroughs for patients who have not achieved complete remission (CR) after multiple rounds of chemotherapy? Research by Chinese medical professors has provided an exciting answer: Eque-cel (BCMA CAR-T therapy).

Patient Background:

This 58-year-old female patient was initially admitted to the hospital due to numbness and pain in both lower limbs and was eventually diagnosed with multiple myeloma. Despite receiving various treatment regimens, including VRD and SVPD, the results were unsatisfactory, and complete remission was not achieved. Faced with refractory characteristics, the doctors decided to try a more innovative treatment plan—CAR-T cell therapy.

Treatment Process:

In September 2023, the patient began peripheral blood mononuclear cell collection, followed by bridging therapy, and in November 2023, she received the Eque-cel infusion. Remarkably, just one month later, the patient achieved hematologic complete remission (CR) with minimal residual disease (MRD) negativity. After six months of follow-up, the patient maintained this excellent therapeutic effect.

Professor’s Insights:

Chinese medical professors pointed out that the advent of Eque-cel has brought new hope to refractory MM patients. The drug demonstrated significant efficacy in the FUMANBA-1 study: the overall response rate was as high as 98.9%, with 82.4% achieving complete remission, and 97.8% of patients achieving MRD negativity. The 12-month sustained MRD negativity rate reached 81.7%, and the PFS rate was 85.5%.

This outstanding result proves the significant advantage of Eque-cel in improving the depth of remission for MM patients, bringing hope for long-term survival to many refractory patients.

Future Outlook:

As the application and research of Eque-cel continue, we look forward to it providing better treatment options and survival opportunities for more MM patients. This new treatment plan is bringing a ray of hope to this stubborn disease and providing valuable experience for clinical experts worldwide.

Stay Tuned:

We will continue to follow the latest developments and research progress of Eque-cel, looking forward to its greater role globally, bringing hope and blessings to more 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

Email: doctor.huang@globecancer.com

#MultipleMyeloma #CARTTherapy #MedicalBreakthrough #EqueCel #CancerTreatment #MedicalResearch #Hematology #PatientCare #OncologyInnovation #HopeForPatients #BCMA #CART #MM #RRMM

1 month ago Myeloma

Chinese Medical Team: Long Survival and Significant Benefits with BCMA CAR-T Treatment for RRMM: A 5-Year Outlook

RRMM

Chimeric antigen receptor (CAR) T-cell therapy is one of the most promising new treatments for relapsed/refractory multiple myeloma (RRMM), but reports on its long-term efficacy and safety are limited. As early as 2022, Professor Du Juan’s team from the Department of Hematology at Shanghai Changzheng Hospital published a Phase I/II study demonstrating that patients with poor physical status could also benefit from CAR-T therapy. Recently, the team updated their findings with a five-year long-term follow-up, focusing on factors affecting long-term clinical benefits. The results were published in Clinical Cancer Research. The following summary of the study’s content is provided by Cancer Information for readers’ benefit.

### Evidence for Long-Term Efficacy and Safety of BCMA CAR-T Cell Therapy

#### Patient Characteristics

The study included 49 RRMM patients who had all received at least three prior lines of therapy before undergoing BCMA CAR-T cell treatment. At enrollment, 20 patients (40.82%) had poor physical status (ECOG performance status of 3-4), 42.86% had high-risk cytogenetic features, and 63.27% had received four or more lines of treatment. At the time of infusion, 79.59% had progressive disease. Among the patients with poor physical status, 30% had extramedullary disease (EMD), 45% had high-risk cytogenetic features, 70% had received four or more lines of treatment, and 80% had progressive disease after their last line of treatment.

#### Efficacy Evaluation of BCMA CAR-T Cell Therapy HDS269B

After a median follow-up of 59.0 months, the study showed an overall response rate (ORR) of 77.55%. The ORR was similar across patients with different ECOG scores. The median progression-free survival (PFS) was 9.5 months, and the median overall survival (OS) was 20.0 months. The five-year PFS and OS rates were 21.3% and 31.4%, respectively. For patients with ECOG scores of 0-2, the median PFS was 11.0 months, compared to 4.0 months for those with scores of 3-4 (P=0.18). The median OS was 41.8 months for ECOG 0-2 patients and 10.5 months for ECOG 3-4 patients (P=0.015).

Patients who had previously undergone four or more lines of therapy had significantly shorter PFS and OS compared to those who had received fewer than four lines (PFS: P=0.012; OS: P=0.0049). Among the 11 patients with EMD at enrollment, the ORR was 64% for those with EMD and 82% for those without EMD. However, median PFS and OS were notably shorter in patients with EMD (PFS: 3.0 months vs. 10.5 months, P=0.06; OS: 5.0 months vs. 24.0 months, P=0.03).

#### MRD-Negative Status and CAR-T Cell Persistence Indicate Better Long-Term Survival

Minimal residual disease (MRD) negativity was significantly associated with longer PFS and OS. In this study, MRD data were available for 22 patients on day 28 post-infusion, with 14 patients (63.64%) achieving MRD negativity (10^-4). These patients experienced significantly longer PFS and OS compared to MRD-positive patients. Similar associations were observed with MRD status at 3 and 6 months post-infusion.

The expansion of CAR-T cells was also closely related to clinical outcomes. Patients who achieved partial response (PR) or better had higher CAR-T cell peak levels. Patients without disease progression five years post-infusion had significantly higher CAR-T cell expansion peaks than those with progression. Additionally, the duration of CAR-T cell persistence correlated with longer PFS and OS, with patients having CAR-T cells persisting for ≥6 months, ≥12 months, ≥24 months, and ≥36 months showing significantly better PFS and OS than those without detectable CAR-T cells.

#### Controlled Safety Profile of BCMA CAR-T Cell Therapy HDS269B

No new CAR-T cell-related toxicities were observed during long-term follow-up. All patients experienced at least one adverse event (AE), with the most common long-term (≥28 days post-infusion) grade ≥3 AEs being hematologic in nature. No second primary malignancies or delayed immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

This study also included survival analysis, classifying patients by PFS and OS. The results indicated that ECOG 0-2 status, fewer than four prior therapies, and CAR-T cell persistence for ≥6 months were independently associated with longer survival.

### The Potential of BCMA CAR-T Therapy and the Need for Future Optimization

Through a five-year long-term follow-up of 49 RRMM patients, this study systematically evaluated the efficacy and safety of BCMA CAR-T cell therapy HDS269B. The findings suggest that poor physical status is not a contraindication for CAR-T therapy, thus broadening the indications for this treatment. While the results are encouraging, the study has some limitations, including its open-label, single-arm design and small sample size, which, combined with the long follow-up period, could lead to some patient attrition. Furthermore, despite the lack of new severe toxicities, long-term safety requires continued observation.

Overall, this study underscores the importance of BCMA CAR-T cell therapy in the treatment of RRMM and provides a crucial basis for exploring and applying CAR-T immunotherapy in the frontline treatment of multiple myeloma.

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

WhatsApp: +86137 1795 9070

Email: doctor.huang@globecancer.com

#CAR_Therapy #BCMACART #MultipleMyeloma #CancerResearch #LongTermSurvival #MedicalInnovation #Hematology #CancerTreatment #Immunotherapy #OncologyAdvances

2 months ago Myeloma , CAR-T

2024 EBMT : China’s First RRMM CAR-T Therapy Equecabtagene Autoleucel: Efficacy Unaffected by Patients’ Baseline sBCMA Plasma Levels

RRMM

In recent years, CAR-T cell therapy targeting BCMA has emerged as a groundbreaking treatment for multiple myeloma, offering new hope to patients. At the 50th European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting, held from April 14-17, 2024, in Glasgow, the team led by Professor Qiu Lugui presented the latest subgroup analysis results from the FUMANBA-1 study (Abstract OS10-04) on China’s first BCMA-targeted CAR-T therapy, Iquilencel (CT103A).

BCMA (B-cell maturation antigen) is a promising therapeutic target for multiple myeloma (MM), with soluble BCMA (sBCMA) levels in the blood reflecting tumor burden. High sBCMA levels can interfere with the effectiveness of BCMA-targeted therapies, including CAR-T, by competing with cell-surface BCMA for binding, which can lead to reduced efficacy. In contrast, Iquilencel has been designed to minimize the impact of sBCMA on treatment outcomes through careful selection of its single-chain variable fragment (scFv).

The FUMANBA-1 phase II study (NCT05066646) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) has demonstrated that Iquilencel can induce deep and durable responses, with a complete response (CR) rate of 82.4% and a 12-month progression-free survival (PFS) rate of 85.5%. This study aimed to explore whether baseline serum sBCMA levels affect clinical outcomes following Iquilencel infusion.

### Study Methods and Results

The study used enzyme-linked immunosorbent assay (ELISA) to measure serum sBCMA levels and digital droplet PCR (ddPCR) to monitor CAR transgene copy numbers in patients’ peripheral blood. Baseline serum sBCMA levels were classified into high (≥225.1 ng/mL) and low (<225.1 ng/mL) groups. Results showed that high sBCMA levels were significantly associated with high tumor burden, advanced R-ISS and DS stages, and high BCMA expression. However, there were no significant differences in CAR-T cell expansion, AUC (Area Under the Curve) during the first 28 days, or cell persistence between the high and low sBCMA groups.

Patients with high baseline sBCMA levels had overall response rates (ORR) and ≥CR rates of 100% and 80%, respectively, compared to 97.8% and 84% in the low sBCMA group. Analysis showed no significant correlation between baseline characteristics (including sBCMA levels) and CR/sCR achievement. Additionally, there were no significant differences in minimal residual disease (MRD) negativity rates, 18-month sustained MRD negativity rates, PFS, and overall survival (OS) between the two groups.

### Conclusion

The findings from the FUMANBA-1 study indicate that Iquilencel’s efficacy is not influenced by baseline sBCMA levels, making it a universally applicable and promising treatment option for RRMM patients. Its unique fast-dissociation and low-exhaustion properties, similar to those of healthy T-cell receptors, enable Iquilencel to remain effective and persistent in patients’ bodies regardless of sBCMA levels.

Professor Qiu Lugui from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Professor Li Chunrui from Tongji Hospital, Huazhong University of Science and Technology, noted, “sBCMA is an important biomarker of tumor burden in multiple myeloma and a key factor influencing prognosis. Accumulation of sBCMA can inhibit the function of BCMA CAR-T cells. However, our study shows that Iquilencel can overcome the challenges posed by high baseline sBCMA levels, providing significant and lasting responses for RRMM patients.”

These results underscore Iquilencel as an ideal treatment choice for RRMM, offering hope for more effective and long-lasting therapeutic outcomes.

🎉🎉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

#EBMT2024 #CAR_T #MultipleMyeloma #Iquilencel #EquecabtageneAutoleucel #sBCMA #CancerResearch #Immunotherapy #MedicalBreakthrough #Biopharmaceuticals

3 months ago patient story , Myeloma

22 Days from Desperation to Rebirth! Chinese CAR-T Therapy Creates Survival Miracle for Thai Multiple Myeloma Patient

Patient story

Subtitle: Fighting for Love! A story of miraculous rebirth after all treatment options failed for a late-stage multiple myeloma patient in Thailand, who underwent CAR-T therapy in China.

Preface: When all treatment options had been exhausted, cancer progressed rapidly, and doctors regretfully said that Ms. M had no response to any medication. This situation could only lead to palliative care, meaning Ms. M had no chance to fight this disease anymore; her life was now on borrowed time. Fortunately, Ms. M’s family found new hope in China – CAR-T therapy. With the companionship of her family, Ms. M came to China and underwent the world’s first fully human BCMA CAR-T therapy. In just 22 days after treatment, all tumors miraculously disappeared, achieving complete remission (CR), and Ms. M was given a new lease on life!

In June 2021, the life of 58-year-old Ms. M experienced persistent back pain for over months. After detailed examinations at the hospital,resulting in a diagnosis of multiple myeloma. To quickly control the condition, Ms. M received treatments including PCD, DVD, bortezomib and lenalidomide, autologous hematopoietic stem cell transplantation.

In June 2023, the disease relapsed and Ms. M did not respond to any of these treatments. Local doctors informed Ms. M’s family that apart from palliative care, they were powerless, indicating that Ms. M’s life was now on borrowed time! Just as Ms. M was in dire straits, on June 30, 2023, the world’s first fully human BCMA CAR-T therapy – Equecabtagene Autoleucel, was shockingly launched in China, becoming a lifesaving straw for her. Ms. M and her family decided to seek treatment in China.

In September 2023, Professor Li Ping’s team at Shanghai Tongji Hospital developed a personalized Equecabtagene Autoleucel(BCMA CAR-T) therapy plan for Ms. M.

On September 8, 2023, Ms. M finally officially entered the CAR-T treatment process. After all examination items met the requirements, single-cell collection was performed first.

Bridge therapy began on September 11, 2023;

Local radiotherapy to relieve bone pain started on September 24, 2023;

Fludarabine plus cyclophosphamide chemotherapy was administered from October 9-12, 2023;

Finally, on October 14, a small bag of milky-white liquid was infused into Ms. M’s body. The doctor said that inside were billions of “special” T cells that could precisely kill multiple myeloma cells. Once inside the body, they would initiate a mode of frenzied sweeping, wiping out cancer cells completely.

What shocked everyone was that the examination results 22 days after CAR-T treatment showed that Ms. M had achieved hematologic CR, meaning that no cancer cells were detected in her blood. Her pain and anemia were also reversed. It was simply a miracle!

Every day now is precious to Ms. M. She can go shopping, chat with her family, enjoy delicious food with her family, and travel around the world with them, returning to the happy times before she fell ill. The only difference is that Ms. M and her family visit a fixed destination every month now – Shanghai, China. They have become accustomed to hearing the sacred announcement from the doctors here: no cancer in her body, continuing remission.

This is a microcosm of countless cancer patients overcoming the disease. The emergence of CAR-T cell therapy has brought new hope to cancer patients. I believe that in the future, more patients will be able to regain a new life like Ms. M.

Reference：

[1]Yuting Yan, et al. Blood Adv. 2019 Oct 8;3(19)：2895-2904.

[2] 2023 IMS. P-290.

3 months ago patient story

22 Days from Desperation to Rebirth! Chinese CAR-T Therapy Creates Survival Miracle for Thai Multiple Myeloma Patient

Patient story

In July 2017, 58-year-old Ms. M was diagnosed with multiple myeloma. After receiving treatments at the best hospital in Thailand, including PCD, DVD, bortezomib and lenalidomide, autologous hematopoietic stem cell transplantation. The disease rapidly relapsed. Local doctors informed Ms. M’s family that apart from palliative care, they were powerless.

Just as Ms. M was in dire straits, on June 30, 2023, the world’s first fully human BCMA CAR-T therapy – Equecabtagene Autoleucel, was shockingly launched in China, becoming a lifesaving straw for her. Ms. M and her family decided to seek treatment in China.

In September 2023, Professor Li Ping’s team at Shanghai Tongji Hospital developed a personalized Equecabtagene Autoleucel(BCMA CAR-T) therapy plan for Ms. M. What shocked everyone was that the examination results 22 days after CAR-T treatment showed that Ms. M had achieved hematologic CR, meaning that no cancer cells were detected in her blood. Her pain and anemia were also reversed. It was simply a miracle!

Reference：

[1]Yuting Yan, et al. Blood Adv. 2019 Oct 8;3(19)：2895-2904.

[2] 2023 IMS. P-290.

5 months ago Myeloma

#EBMT Conference Reveals the Best CAR-T Therapy for Multiple Myeloma – Equecabtagene Autoleucel

Multiple myeloma

Introduction:

In recent years, there has been a breakthrough in the research of #CART therapy for relapsed and refractory #multiplemyeloma (RRMM). This treatment method holds promise to address the challenges of inadequate response depth and short duration of response in #RRMM patients, offering hope for achieving minimal residual disease (#MRD) negativity and functional cure in this population.

Key Findings at EBMT:

The upcoming 50th European Society for Blood and Marrow Transplantation (EBMT) congress is set to unveil abstracts shedding light on the efficacy of targeted #BCMA CAR-T therapies. A recent abstract titled “Indirect Comparison of the Effectiveness of Targeted BCMA CAR-T Products in RRMM (#MAIC)” for the first time reveals efficacy comparisons among four BCMA CAR-T products. The study demonstrates that Equecabtagene Autoleucel outperforms other BCMA CAR-T therapies in terms of overall response rate (#ORR) and complete response (#CR) rate, offering significant hope for RRMM patients.

#Equecabtagene Autoleucel: Pioneering Fully-human BCMA #CARTTherapy:

#EquecabtageneAutoleucel, the world’s first approved Fully-human BCMA CAR-T therapy, received priority review and approval in China on June 30, 2023. The MAIC analysis underscores its favorable efficacy. This article provides a systematic analysis of the efficacy data of Equecabtagene Autoleucel in the Chinese population over the past two years, as revealed in the dynamic disclosures at various international academic conferences post-approval.

Efficacy Data Highlights:

– In the #FUMANBA-1 Ib/II clinical study conducted in China, the sCR/CR rate reached an impressive 82.4% among RRMM patients.

– The latest data presented at the 2023 International Myeloma Society (#IMS) conference demonstrated a MRD negativity rate of 97.8% among the enrolled patients, indicating substantial tumor burden reduction.

– With a median follow-up of 18.07 months, long-term efficacy data showcased remarkable outcomes, including a median PFS not yet reached, 12-month continuous MRD negativity rate of 81.7%, and 12-month PFS rate of 85.5%.

Differentiating Factors:

– Equecabtagene Autoleucel exhibited shorter median time to response (#TTR) compared to other CAR-T therapies, indicating faster onset of action.

– The dissociation kinetics of Equecabtagene Autoleucel closely resemble those of natural T cells, facilitating efficient activation, killing, and proliferation within the body.

– Its rapid dissociation pattern minimizes CAR-T cell exhaustion, ensuring sustained efficacy and long-term surveillance against tumor recurrence.

Conclusion:

The emergence of Equecabtagene Autoleucel heralds a new era in CAR-T therapy for RRMM, offering superior efficacy and durable responses. With its unique structural advantages and promising clinical data, Equecabtagene Autoleucel stands as a beacon of hope for RRMM patients worldwide, bringing them closer to achieving disease control and improved quality of life.

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

Email: doctor.huang@globecancer.com

WhatsApp: +8613717959070

#chineseMedicine #chineseresearch #cancerresearch #cancertreatment #myeloma #bloodtumor #cancer #cancerreseach

5 months ago CAR-T

🎉 #PNAS Breaking News: Revolutionary CAR-T Cell Therapy Successfully Treats Autoimmune Disease in China! 🎉

PNAS

In a groundbreaking development, Chinese medical experts have achieved a milestone in the treatment of autoimmune diseases using CAR-T cell therapy.

🩺 A New Hope for Autoimmune Diseases

Autoimmune-mediated necrotizing myopathy (#IMNM) poses a significant challenge in clinical management due to its severe symptoms and limited efficacy of traditional pharmacological approaches. However, a ray of hope emerges with the application of Chimeric Antigen Receptor (CAR) T-cell therapy targeting B cell maturation antigen (#BCMA).

🔬 The Breakthrough Study

Published in the prestigious #journal PNAS, the study titled “Single-cell analysis of refractory anti-SRP necrotizing myopathy treated with anti-BCMA CAR-T cell therapy” by the medical team at Huazhong University of Science and Technology sheds light on a remarkable case. A patient with anti-signal recognition particle (SRP) IMNM exhibited significant improvement in clinical symptoms and sustained reduction in pathogenic autoantibodies after receiving BCMA-targeted CAR-T cell therapy for over 18 months.

🧬 Understanding the Mechanisms

Through longitudinal single-cell RNA sequencing and analysis of T cell receptors and B cell receptors, researchers elucidated the normalization of the immune microenvironment post-CAR-T cell infusion. The expansion of CD8+ CAR-T cells, coupled with dynamic phenotypic transitions in both CD4+ and CD8+ CAR-T cells, was observed, indicating a promising avenue for the treatment of autoimmune diseases.

🔍 Implications for the Future

This study not only highlights the efficacy of CAR-T cell therapy in refractory IMNM but also underscores the importance of understanding the molecular characteristics of CAR-T cells in autoimmune diseases. Further research is warranted to enhance the efficiency and durability of CAR-T cell therapy for autoimmune conditions.

🌟 Hope for Patients Worldwide

With this groundbreaking achievement, there is renewed hope for millions of individuals battling autoimmune diseases globally. Stay tuned for more updates as we continue to unlock the potential of innovative therapies in medical science!

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

Email: doctor.huang@globecancer.com,

WhatsApp: +8613717959070

#CAR_TTherapy #AutoimmuneDisease #MedicalBreakthrough #Science #Innovation #PNAS #cart #cartcell #BCMA #IMNM #chineseresearch #medicalscience

6 months ago Myeloma

Another BCMA CAR-T therapy for multiple myeloma hits the market in China! – 🔥Long-term efficacy 🔥

🌎Another BCMA CAR-T therapy for multiple myeloma hits the market in China!

– 🔥Long-term efficacy 🔥

multiple myeloma

🌙China has made significant breakthroughs in the treatment of multiple myeloma with BCMA CAR-T therapy, attracting global attention. Recently, two fully human BCMA CAR-T therapies, Equecabtagene Autoleucel and Zevorcabtagene Autoleucel, have been approved for the treatment of relapsed/refractory multiple myeloma.⭐️

🌛 In terms of long-term efficacy, for patients with a CAR-T cell persistence of over one year, the percentage is 53.3% for Equecabtagene Autoleucel and 26.5% for Zevorcabtagene Autoleucel at six months’ persistence.⭐️

🌜The duration of CAR-T cell persistence has an impact on the survival outcome of multiple myeloma (MM) patients. Long-term follow-up data from the Lengend-2 study showed a significant improvement in the cumulative overall survival (OS) rate for RRMM patients with a CAR-T cell persistence of over 280 days compared to patients with a persistence of less than 280 days. Therefore, 280 days of persistence is a critical threshold for improving clinical outcomes.⭐️

✨The median persistence for Zevorcabtagene Autoleucel is 77 days, while for Equecabtagene Autoleucel, it is 419 days, far exceeding the critical threshold. It is expected to improve the OS of MM patients.⭐️

🌤From a clinical perspective, both therapies demonstrate a trend of improving long-term efficacy over time.

The complete response (CR) rate at six months of follow-up is 54.8% for Equecabtagene Autoleucel and 35.0% for Zevorcabtagene Autoleucel.⭐️

🌝At a median follow-up of around nine months, the registered clinical data from China shows a CR rate of ≥74.2% for Equecabtagene Autoleucel and 45.1% for Zevorcabtagene Autoleucel.⭐️

🌞During the 2023 IMS conference, Equecabtagene Autoleucel presented the latest long-term follow-up data, revealing a further increase in the CR rate to 82.4% at a median follow-up of 18.07 months.⭐️

☀️The efficacy data following a median follow-up of nine months for Zevorcabtagene Autoleucel in the registered clinical trial LUMMICAR-1 Phase 2 study has not been publicly disclosed.

China’s breakthroughs in CAR-T cell therapy are remarkable. It not only provides new treatment options for multiple myeloma patients but also demonstrates China’s strength in medical research and innovation. It brings hope and possibilities for improving patients’ survival and quality of life.⭐️

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

WhatsApp: 137 1795 9070

Email: doctor.huang@globecancer.com

#BCMACART #MultipleMyeloma #Innovation #CART #CARTTherapy #chinesemedical

6 months ago Myeloma

Another BCMA CAR-T therapy for multiple myeloma hits the market in China! – Short-term efficacy

Another BCMA CAR-T therapy for multiple myeloma hits the market in China!

– Short-term efficacy

multiple myeloma

China CAR-T therapy

In recent years, CAR-T cell therapy has achieved tremendous success in treating hematologic malignancies. Over the past 11 years, China has seen a surge in clinical trials evaluating the safety and efficacy of CAR-T therapy. China has now surpassed the United States as a major force in CAR-T clinical research.

In the field of multiple myeloma (MM),

China has gained regulatory approval from the NMPA for two fully human BCMA CAR-T therapies for the treatment of relapsed/refractory MM (R/R MM). These therapies are Equecabtagene Autoleucel and Zevorcabtagene Autoleucel.

BCMA

While both therapies target the same BCMA and share a common co-stimulatory domain, there are some fundamental differences between them. Zevorcabtagene Autoleucel includes patients with stable disease after previous treatment, whereas Equecabtagene Autoleucel focuses on patients with relapsed or progressive MM.

Looking at the short-term efficacy

The median time to peak CAR-T cells in peripheral blood is 12 days for Equecabtagene Autoleucel and 14 days for Zevorcabtagene Autoleucel. This indicates that the former can rapidly exert its effect, potentially laying the foundation for achieving clinical remission faster and better.

Clinical trial results seem to support this notion, with Equecabtagene Autoleucel showing a median time to response (TTR) of 15 days, compared to 29 days for Zevorcabtagene Autoleucel. At the 3-month follow-up, the complete remission rates were 40.3% for Equecabtagene Autoleucel in the registered clinical trial FUMANBA-1 1b/2 phase, surpassing the rate of 28.3% observed in the registered clinical trial LUMMICAR-1 phase 2 for Zevorcabtagene Autoleucel.

It’s worth noting that the infusion dose for Equecabtagene Autoleucel is 1×106 cells/kg, while the total infusion dose for Zevorcabtagene Autoleucel is 150×106 cells, which translates to double the dose of Equecabtagene Autoleucel for patients with a weight of 70kg-75kg. Additionally, the reinfusion dose for Zevorcabtagene Autoleucel is not fixed and needs to be increased to 1.8×108 cells for patients weighing ≥80kg.

With the increasing availability of these groundbreaking BCMA CAR-T therapies, the landscape of multiple myeloma treatment continues to expand, offering more possibilities and choices.

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

WhatsApp: 137 1795 9070

Email: doctor.huang@globecancer.com

#BCMACART #MultipleMyeloma #Innovation #CART #CARTTherapy #chinesemedical Advanced Medicine in China

6 months ago 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.

🌈 $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.

multiple myeloma

Zevor-cel

🌦On March 5th, the fifth approved CAR-T therapy in China, Zevor-cel injection (Zevor-cel) by CARsgen, was priced at $116,000 for its initial release.

Zevor-cel injection is an autologous CAR-T product targeting BCMA. It is the fifth CAR-T therapy approved and marketed in China, following Axicabtagene Ciloleucel by Fosun Kite, Relmacabtagene Autoleucel by JW Therapeutics, Equecabtagene Autoleucel by IASO Bio, and Inaticabtagene Autoleucel by Juventas.

Cheapest CAR-T therapy

🌺Currently, the cheapest approved CAR-T therapy in the world is Inaticabtagene Autoleucel by Juventas. The price has dropped below one million RMB, at 999,000 RMB (equivalent to less than $140,000).

US CAR-T

🌼In 2017, the US FDA approved two CAR-T products, marking the beginning of the era of immunocellular therapy. CAR-T therapy has always been known for its high prices. Just how expensive is it? The two CAR-T therapies approved for sale in the United States are priced at $475,000 (Kymriah) and $373,000 (Yescarta), and these are just the prices of the drugs themselves. The total cost of the treatment far exceeds these amounts.

Multiple Myeloma

🌻For the treatment of multiple myeloma, there are currently two CAR-T products on the US market: Idecabtagene vicleucel by BMS/bluebird bio and ciltacabtagene autoleucel by Legend Bio. They are priced at $419,000 and $465,000, respectively, with a BCMA target and a complete response (CR) rate of 28% and 78%.

In China

⚡ there are also two CAR-T products on the market: Zevor-cel injection by CARsgen and Equecabtagene Autoleucel injection by IASO Bio. They are priced at $160,000 and $162,000, respectively, with the same BCMA target and CR rates as high as 78.6% and 82.4%.

🌤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+8613717959070

doctor.huang@globecancer.com

#CARTtherapy #CancerTreatment #Immunotherapy #MultipleMyeloma #BCMA #Zevorcel #CARsgen #MedicalBreakthrough #HealthcareInnovation #PrecisionMedicine #PersonalizedMedicine #MedicalAdvancements #FightAgainstCancer #GlobalHealthcare #AffordableMedicine

#CancerResearch #PatientCare #MedicalTechnology #InnovativeTherapy #HopeForPatients

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