CAR-T Clinical Study Project Approved by China National Center for Biotechnology Development

Background

CAR-T cell therapy has transformed outcomes for certain blood cancers but faces substantial challenges when applied to solid tumors. Metastatic castration-resistant prostate cancer (mCRPC) represents an advanced stage where the disease progresses despite hormone therapy and has spread beyond the prostate. Treatment remains difficult, with current options often focused on prolonging survival rather than achieving durable remission.

The First Bethune Hospital of Jilin University has built experience in cellular immunotherapy. Its cell therapy center was established in 2010. On March 30, 2026, the center completed a strategic upgrade and was officially renamed the Cell and Gene Therapy Center (CGT Center). This occurred alongside national regulatory updates, including State Council Order 818, which established strict standards for institutions regarding comprehensive strength, quality control systems, academic review, and ethics oversight in biomedical new technology clinical research.

What was achieved

On October 19, 2026, the China National Center for Biotechnology Development approved a single-center clinical research project. The project is led by Cui Jiuwei, Director of the Oncology Department at The First Bethune Hospital of Jilin University, and conducted in collaboration with Shanghai Simnova Biotechnology Co., Ltd. It evaluates a CAR-T regimen in patients with metastatic castration-resistant prostate cancer.

The study specifically aims to assess the safety and tolerability of the CAR-T treatment approach and to explore its clinical application potential in solid tumors. According to the hospital announcement, this is the hospital's first project approved under the new State Council regulations. Hospital statements note that the approval relies on the oncology department's long-term accumulation of clinical diagnosis, treatment, and research experience. It is characterized as having milestone significance for the hospital's biomedical new technology development. The CGT Center intends to use the approval to follow frontiers in cell and gene therapy, strengthen infrastructure, perfect full-process clinical research quality management, and accumulate standardized research practice experience.

How it works

CAR-T therapy is a personalized form of immunotherapy. The process begins with collecting the patient's T cells, a type of immune cell responsible for recognizing and destroying abnormal cells, typically through apheresis from the blood. In a controlled laboratory environment meeting GMP standards, these T cells are genetically modified using a viral vector to insert DNA encoding a chimeric antigen receptor, or CAR. The CAR protein on the cell surface is engineered to bind to a specific target antigen expressed by the cancer cells.

After genetic modification, the CAR-T cells are expanded to large numbers in culture. They are then infused back into the patient. Once in the body, the engineered cells are designed to recognize the target on tumor cells, become activated, multiply further, and kill the cancer cells through direct cytotoxic mechanisms and by recruiting other immune responses. In solid tumors such as mCRPC, the dense tumor microenvironment and heterogeneous antigen expression can limit effectiveness compared to blood cancers. Clinical studies therefore prioritize evaluating safety, tolerability, cytokine release patterns, and any observed biological activity in this setting before broader application.

What it means for international patients

The hospital maintains an International Clinic within its VIP services, established in 2014. It provides one-stop medical services and whole-process guidance for foreign patients, including multilingual support in languages such as English and Japanese, priority registration, expert consultations, MDT discussions, and dedicated facilities. These services cover patients from overseas, high-level experts, and those seeking specialized care.

The approval of this CAR-T project for mCRPC indicates the hospital's expanding research infrastructure and capabilities in solid tumor cell and gene therapy following national regulatory updates. International patients exploring innovative options for advanced prostate cancer or similar conditions may find such developments relevant. Clinical trials have specific inclusion and exclusion criteria, rigorous ethical oversight, and are conducted at defined stages. Patients must confirm current eligibility, trial status, and suitability directly with the hospital, as participation depends on individual medical evaluation and availability.

About the hospital

The First Bethune Hospital of Jilin University, also referred to as Jilin University First Hospital, is located in Changchun, the capital of Jilin Province. It is a comprehensive tertiary Grade A general hospital affiliated with Jilin University and under the administration of the National Health Commission of China. The hospital integrates medical care, education, scientific research, and disease prevention.

It has 28 national key clinical specialties. It is the only institution in Jilin Province qualified for liver, kidney, heart, and lung transplantation, with organ donation and transplant volumes ranking first in Northeast China and in the national top ten; transplant success rates and related indicators are reported among leading national levels. In the 2022 national performance assessment of tertiary public hospitals, it received an A+ rating and ranked 18th nationwide. The hospital operates dedicated international medical services, including at its Lequn campus, and maintains an English-language portal for international patients. Its oncology department and newly upgraded Cell and Gene Therapy Center form part of its profile in innovative cancer care and research.