In recent years, cancer treatment has seen significant progress, with tumor immunotherapy emerging as a prominent approach for end - stage cancer patients. Since the approval of Kymriah (for leukemia) and Yescarta (for lymphoma) in 2017, CAR-T cell therapy has achieved remarkable success in blood - related cancers.

However, applying CAR-T therapy to solid tumors presents challenges such as identifying specific targets, dealing with tumor heterogeneity, and achieving effective tumor infiltration. These issues limit the efficacy of CAR-T therapy in solid tumors, largely because T cells have difficulty penetrating the tumor microenvironment.

Macrophages in the immune system show promise for solid tumor treatment. Research indicates that CAR-M, derived from macrophages, can precisely target tumor cells, minimize harm to healthy cells, and enhance the phagocytic and antigen-presenting capabilities of macrophages.

Using myeloid-derived macrophages as a cell therapy platform leverages their unique killing and tumor-penetrating abilities to overcome solid tumor challenges like infiltration, immune suppression in the tumor microenvironment, lymphocyte exclusion, and target antigen heterogeneity.

Macrophages can infiltrate tumors due to their unique abilities, unlike T cells hindered by tumor stroma. Genetically engineered macrophages can differentiate into pro-inflammatory M1 type, phagocytose tumor cells, and secrete cytokines to alter the tumor microenvironment, influencing tumor invasion, metastasis, immune suppression, and angiogenesis.

Compared to CAR-T, CAR-M demonstrates stronger tumor-specific phagocytosis and clearance, both in vivo and in vitro. It can present antigens to activate T cells for tumor killing and has a shorter circulation time, reducing non-tumor-targeted toxicity.

IITs are common globally, led by medical institutions to explore new treatments or drug uses, complementing industry - initiated trials, promoting drug research, providing data for evidence-based medicine, and aiding innovative drug development.

Jiangsu Juechuang Bio-technology Research Institute Co., Ltd., supported by Xuzhou Medical University and Jiangsu Institute of Tumor Biotherapy, is the only cell - therapy - drug - focused research institute in the Yangtze River Delta region. It aims to build a top - notch domestic tumor biotherapy technology platform integrating R & D, transformation, and clinical application. With over two decades of cell therapy research and industry experience, and a mature R & D and clinical transformation team, the company has developed multiple fully human CAR-T pipelines and initiated several IITs.

The Affiliated Hospital of Xuzhou Medical University houses a national Phase I Clinical Research Center. Its Ethics Committee obtained SIDCER-FERCAP certification in 2015, ranking its ethics review technology and management among the nation's best. It is the only FERCAP - certified ethics committee in the Huaihai Economic Zone. The hospital has initiated over 40 CAR-T immunotherapy clinical trials and is a leader in CAR-T clinical trials nationwide.

RocRock Bio's CAR-M platform has shown effective anti-tumor activity in preclinical solid tumor models. The strategic cooperation with Jiangsu Juechuang Bio-technology Research Institute Co., Ltd. significantly accelerates CAR-M IIT clinical research. CAR-M immunotherapy offers a promising approach for solid tumor treatment, bringing hope to end-stage cancer patients who have exhausted other treatment options.