On September 3, the National Medical Products Administration (NMPA) officially approved Relmacabtagene Autoleucel (Brand name: Carteyva), a CD19 CAR-T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
About Carteyva (relmacabtagene autoleucel)
Carteyva is an autologous CAR-T cell immunotherapy product targeting human CD19, developed by JW Therapeutics based on the Breyanzi platform from Juno Therapeutics. It is also the first domestically approved Class 1 new CAR-T drug in China indicated for the treatment of relapsed/refractory LBCL. The approval is based on results from a prospective, single-arm, multi-center, pivotal study conducted in China, which validated its efficacy and safety in Chinese patients with relapsed/refractory LBCL.
What are the unique mechanisms and therapeutic advantages of Relmacabtagene Autoleucel in treating lymphoma?
Professor Wang Jianxiang stated:
“Relmacabtagene Autoleucel is a specially modified immune therapy cell that can recognize the human CD19 antigen and exert targeted immune-killing effects against leukemia and lymphoma tumor cells. It is administered as a single infusion, avoiding the side effects caused by repeated chemotherapy. This immunotherapy cell has a special structure, particularly the 4-1BB co-stimulatory domain, which helps prolong T-cell activation and thus maintains anti-tumor activity for a longer duration. As a result, the cells persist longer in the body and exert sustained anti-tumor effects. At the same time, Relmacabtagene Autoleucel provides immune surveillance and activation by recognizing antigens, activating T cells, and maintaining their survival—broadly stimulating the body’s immune system to kill tumor cells. This brings long-lasting efficacy and durable benefits to patients. Overall, Relmacabtagene Autoleucel offers a very effective immunotherapy option for lymphoma patients and has achieved excellent results.”
How does Relmacabtagene Autoleucel differ from conventional therapies for LBCL in terms of efficacy and treatment approach?
Professor Zhou Jianfeng stated:
“Relmacabtagene Autoleucel is an anti-CD19 CAR-T product that differs from all previously existing drugs, including monoclonal antibodies and targeted therapies. It is a living drug with unique advantages and superior efficacy. As we know, conventional drugs typically require long-term continuous administration. In contrast, Relmacabtagene Autoleucel is administered as a one-time treatment. After infusion, CAR-T cells can persist in the body—sometimes even for life—delivering results that are unmatched by previous treatments. A single infusion can provide long-term benefits for patients.”
What long-term benefits can patients expect from a single infusion of CAR-T therapy like Relmacabtagene Autoleucel, and how does it prevent relapse?
Professor Cao Junning commented:
“After a single infusion of CAR-T therapy, patients can return to normal life, avoiding the long-term high exposure risks associated with traditional therapies. The 4-1BB co-stimulatory domain used in Relmacabtagene Autoleucel helps prevent T-cell exhaustion and prolongs CAR-T cell persistence, resulting in sustained anti-tumor effects. The CAR-T cells not only remain and proliferate in the body but also acquire immune memory, allowing for ongoing immune surveillance. They can recognize, attack, and eliminate mutated cells, preventing relapse. This enables patients to gain long-term survival benefits. Clinical cases have shown that patients who achieved sustained complete remission (CR) after CAR-T therapy still had detectable vector copies three years post-infusion.”
Why is the approval of Relmacabtagene Autoleucel considered a major milestone for China’s CAR-T therapy development?
Professor Shen Zhixiang stated:
“Relmacabtagene Autoleucel is China’s first Class 1 biologic innovative drug and the first CAR-T product to complete its registration clinical trial entirely within China. Its registration trial is also the largest CAR-T clinical trial in China to date. All enrolled patients in the clinical trials were from China, and over 80 patients with relapsed/refractory LBCL received infusion therapy in Phase I and Phase II studies. It is a CAR-T product developed in China and for use in China in the truest sense.”
How does the China-based clinical trial data for Relmacabtagene Autoleucel enhance its relevance and reliability for Chinese lymphoma patients?
Professor Song Yuqin added:
“All patients enrolled in the Relmacabtagene Autoleucel clinical trials were Chinese patients with relapsed/refractory diffuse large B-cell lymphoma. Through both Phase I and II studies, a total of more than 80 patients were enrolled. Therefore, all registration data for Relmacabtagene Autoleucel are based on Chinese patients. This provides important real-world evidence and guidance for future clinical application. With data rooted in Chinese clinical experience, the therapy may better meet the practical needs of Chinese doctors and patients. We hope Relmacabtagene Autoleucel will be launched as soon as possible to benefit more patients.”
