The World’s First! China’s Non-Viral Site-Specific Integrated PD1-CAR-T Therapy Brings New Hope for Systemic Lupus Erythematosus(SLE) Patients

**The World’s First! China’s Non-Viral Site-Specific Integrated PD1-CAR-T Therapy Brings New Hope for Systemic Lupus Erythematosus(SLE) Patients**

SLE

#PD1 #CART #SLE #SystemicLupusErythematosus #Lupus #CARTTherapy #BRL203 #Nature

In November 2024, Chinese gene and cell therapy company BRL Medicine announced that its self-developed non-viral site-specific integrated PD1-CAR-T therapy, “BRL-203,” has received clinical trial approval from the National Medical Products Administration (NMPA) of China. This groundbreaking therapy aims to treat moderate to severe refractory systemic lupus erythematosus (SLE) and is the world’s first non-viral site-specific integrated CAR-T product approved for autoimmune disease treatment. This innovation brings new possibilities in lupus treatment and offers global patients a safer and more effective treatment option.

### Disruptive Treatment Brings Hope to Lupus Patients

Systemic lupus erythematosus (SLE) is a severe autoimmune disease that can lead to irreversible organ damage due to relapse and progression, severely affecting patients’ quality of life and even life expectancy. In recent years, SLE has garnered widespread attention and discussion, highlighting the urgent need for new therapies to alleviate patients’ suffering and extend their lives. While existing treatments can control the disease to some extent, they still rely on long-term immunosuppressive drugs, with suboptimal effectiveness and a high risk of relapse.

BRL Medicine’s non-viral site-specific integrated PD1-CAR-T therapy, “BRL-203,” offers a new treatment option for SLE patients. As a novel CAR-T cell therapy, it is expected to open a new era in autoimmune disease treatment, providing patients with sustainable disease control and reducing the risk of relapse.

### Chinese Non-Viral CAR-T: Overcoming Safety and Efficiency Challenges of Traditional Therapies

BRL Medicine’s “BRL-203” utilizes self-innovated non-viral site-specific integration technology, employing CRISPR/Cas9 gene-editing to precisely target the PD1 site and insert CAR molecules that target CD19. This non-viral method avoids the potential tumorigenic risks of traditional viral vector production, significantly enhancing the safety of the product. Moreover, the therapy preparation takes only 3 days, greatly reducing the patient’s waiting time and lowering production costs, making it more accessible and affordable for patients.

Compared to traditional CAR-T products, which face challenges such as long production cycles, high costs, and potential risks, BRL Medicine’s non-viral site-specific integrated PD1-CAR-T platform not only enhances safety but also significantly improves clinical applicability. Previously, BRL Medicine’s other non-viral PD1-CAR-T therapy demonstrated excellent safety and efficacy in treating relapsed/refractory B-cell non-Hodgkin lymphoma (r/r NHL), with research results published in *Nature* magazine, earning widespread recognition in the medical community.

### Precise Targeting and Safe, Controllable Innovative Therapy

Unlike traditional random integration methods, China’s non-viral site-specific integration technology ensures that each CAR sequence is precisely placed at a designated location in the genome, reducing the risk of tumor formation during treatment. This breakthrough technology ensures product uniformity and significantly improves clinical safety. In early clinical trials, BRL Medicine’s PD1-CAR-T therapy achieved a 100% objective response rate (ORR), an 85.7% complete response rate (CR), with almost no high-risk side effects.

### Future Outlook: Diversified Options for Autoimmune Disease Treatment

The approval of BRL Medicine’s non-viral site-specific integrated PD1-CAR-T product is not only a boon for lupus patients but also a significant breakthrough in the global autoimmune disease treatment field. The company will accelerate the subsequent clinical progress of BRL-203, aiming to develop it into an efficient, safe, and accessible innovative therapy, bringing new hope to more patients.

🎉🎉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

#BRLMedicine #CAR_T #LupusTreatment #AutoimmuneDisease #NonViralTherapy #GeneTherapy #InnovativeMedicine #SLE #ClinicalTrials #MedicalBreakthrough