In Vivo CAR-T Therapy SNC116 Completes First Patient Enrollment

Background

Chimeric antigen receptor T-cell (CAR-T) therapy has provided new treatment options for patients with relapsed or refractory B-cell malignancies by reprogramming T cells to target antigens such as CD19 on cancer cells. Traditional autologous CAR-T therapies involve collecting a patient's T cells through apheresis, genetically modifying them in a specialized laboratory using viral vectors, expanding the modified cells, and infusing them back into the patient after lymphodepleting chemotherapy. This ex vivo manufacturing process typically requires several weeks, involves high costs, faces risks of manufacturing failure, and is available only at select specialized centers, restricting broader patient access.

What was achieved

In late October 2025, Shanghai Simnova Biotechnology Co., Ltd. (founded in 2019 as a subsidiary of Simcere Pharmaceutical and independently operated since 2021) announced that clinical research for its investigational in vivo CAR-T product SNC116 had been initiated at the Cancer Hospital of the Chinese Academy of Medical Sciences, with enrollment of the first patient successfully completed.

Simnova CEO Dr. Cao Zhuoxiao stated that the company was proud to collaborate with the hospital's top team and described the first patient enrollment as a key milestone in advancing the disruptive technology from concept to clinical validation. The study's principal investigator, Li Ning of the hospital, remarked that in vivo CAR-T technology represents a future direction and has the potential to address core bottlenecks in accessibility and timeliness of existing CAR-T therapies. He characterized the enrollment as a good start and affirmed that the research would be advanced with a rigorous scientific approach.

How it works

Traditional CAR-T therapy extracts a patient's T cells, introduces genetic material encoding a chimeric antigen receptor (CAR) that enables the T cells to recognize and attack CD19-expressing cancer cells, grows large numbers of these engineered cells in a laboratory over a period of weeks, and returns them to the patient. The process demands dedicated manufacturing facilities, specialized expertise, and significant time, during which a patient's disease may progress.

SNC116 uses an in vivo approach with a lentiviral vector. The prepared vector is administered by intravenous infusion. It is engineered with T-cell specific promoters and a transfection system designed to deliver the CAR gene preferentially and efficiently into the patient's own circulating T cells directly within the body. Once inside the appropriate cells, the gene directs production of the CD19-targeted CAR on the T-cell surface, enabling them to recognize and eliminate CD19-positive malignant B cells. This method aims to bypass the need for external cell collection, laboratory manufacturing, and associated delays.

What it means for international patients

The initiation of this investigator-initiated clinical study at a leading Chinese cancer center reflects continued development of next-generation cell therapies in China that seek to improve upon limitations of conventional CAR-T approaches. The Cancer Hospital of the Chinese Academy of Medical Sciences operates a dedicated Special Medical Department (also known as the VIP or international medical services unit). This department supports international patients with services that include bilingual (Chinese-English) guidance, coordination of multidisciplinary team consultations, remote consultation options, and issuance of required medical documentation. The hospital, including its Langfang campus designated as an international medical service unit, has treated foreign patients from multiple countries such as Russia, the United States, and South Korea.

As an early exploratory clinical study focused on safety, pharmacokinetics, and preliminary activity in specific relapsed or refractory CD19-positive B-cell malignancies, patient eligibility is determined by strict inclusion and exclusion criteria including disease subtype, performance status, organ function, and prior therapies. International patients considering care in China or participation in this or similar trials should contact the hospital's clinical research office or international medical department directly to verify current trial status, eligibility, required documentation such as medical records and imaging, and any visa or logistical support. Participation decisions rest exclusively with the hospital's physicians.

About the hospital

The Cancer Hospital, Chinese Academy of Medical Sciences is located at No. 17 Panjiayuan Nanli in Beijing's Chaoyang District. Founded in 1958 as Ritan Hospital, it was the first specialized cancer hospital established in the People's Republic of China. It is a Grade 3A tertiary specialist oncology hospital affiliated with the Chinese Academy of Medical Sciences and serves as the National Cancer Clinical Medicine Research Center, the National Cancer Standardized Diagnosis and Quality Control Center, and a National Drug Clinical Research Center.

The hospital maintains approximately 1,500 beds and reports annual outpatient visits exceeding one million, roughly 76,000 inpatients, and more than 32,000 operations. It consistently ranks first among tertiary oncology specialty hospitals in national performance evaluations of public hospitals. The institution emphasizes integrated cancer prevention, treatment, research, and education, with national key laboratories, multiple national key disciplines, and publications in high-impact journals including Nature, The Lancet, and Cell. It conducts a large volume of clinical trials and maintains an active international cooperation program.