IASO Bio Announces First Patient Enrolled and Leukapheresis Completed in Phase I/II Registration Clinical Trial of CT120, a Fully Human Dual-Targeting CD19/CD22 CAR-T Therapy

IASO Bio Announces First Patient Enrolled and Leukapheresis Completed in Phase I/II Registrational Clinical Trial of CT120, a Fully Human Dual-Targeted CD19/CD22 Chimeric Antigen Receptor Autologous T-cell Injection, for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This marks the first fully human dual-targeted CAR-T therapy approved for clinical stage in China. Meanwhile, the clinical trial of CT120 for treating relapsed/refractory acute B lymphoblastic leukemia (B-ALL) is also about to commence.

This study is a Phase I/II, multi-center clinical trial (Registration No.: CTR20212328). The Phase I portion aims to evaluate the safety and tolerability of CT120 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, and to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of CT120. The Phase II portion aims to assess the efficacy of CT120 in treating B-NHL patients.

The principal investigator of this study, Zhou Jianfeng from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated:"This clinical trial has significantly reduced the financial burden on patients, giving them the possibility of benefiting from the new drug at an earlier stage."CT120 is the first dual-target CAR-T to enter the clinical stage. Compared with existing single-target CAR-T therapies, it is expected to further reduce the risk of tumor recurrence and extend patient survival time in clinical practice.In exploratory clinical trials, CT120 has demonstrated good safety and efficacy.Our hospital will adhere to the principles of ethics and science, and work together with all cooperating units to advance the trial, benefiting more patients.”

IASO Bio CEO Dr. Wang Wen stated:

"On October 13 this year, we obtained the approval from the National Genetic Office for this project. On October 14, we signed a research contract with Tongji Hospital, and promptly held the project kick-off meeting on the 15th. After screening, we enrolled the first participant at the end of October. We are very grateful to Professor Zhou Jiatao, the PI from Tongji Hospital, and his team for maintaining close communication with the IASO Bio team, ensuring seamless cooperation throughout the process. CT120 is the world's first fully human dual-target CAR-T product and also a highly innovative product independently developed by IASO Bio. IIT studies have shown that CT120 not only benefits participants with relapsed/refractory B-NHL and B-ALL who have not received CAR-T therapy but also benefits those who previously received non-human single-target CAR-T treatment and experienced disease progression. Currently, the company has more competitive products in the pipeline for IND applications. We look forward to continuing to develop more innovative fully human products based on the company’s globally leading fully human phage antibody library, fulfilling our mission of 'making innovative therapies a cornerstone treatment for curing patients.'"

About CT120

CT120 is an autologous chimeric antigen receptor T-cell injection targeting CD19 and CD22. The CAR molecule's extracellular domain of this product contains two fully human single-chain variable fragment (scFv) sequences that specifically bind to CD19 and CD22, reducing tumor cell escape caused by target antigen loss through the recognition of tumor cells expressing CD19 and/or CD22. With a fully humanized design, it exhibits low immunogenicity, which can reduce the risk of anti-drug antibody (ADA) production and improve the long-term persistence of CAR-T cells in vivo. Additionally, the intracellular co-stimulatory signals of this product utilize 4-1BB and CD3ζ, which, compared with CD28 co-stimulatory signals, reduce the risk of neurotoxicity and further enhance the long-term persistence of CAR-T cells, strengthening long-term efficacy. After binding to CD19 and/or CD22 antigens on the target cell membrane, this product directly kills target cells by releasing granzymes/perforin while releasing cytokines to stimulate CAR-T cell expansion, continuously exerting anti-tumor effects.

About NHL

Lymphoma originates from immune system cells and can affect any organ in the body, accompanied by complex pathological processes. Lymphoma is divided into Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). NHL accounts for approximately 90% of lymphomas, and about 85% of NHL cases are B-cell non-Hodgkin lymphoma (B-NHL). B-NHL can be further classified into subtypes such as diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and small lymphocytic lymphoma (CLL). According to a Frost & Sullivan report, there were 92,800 new cases of non-Hodgkin lymphoma in China in 2020, with the number of patients reaching 514,200 in 2020, and it is estimated to reach 632,300 by 2025. The mortality rate of NHL is high, with a five-year survival rate of only 37% in China.

About IASO Bio

IASO Bio is an innovative biopharmaceutical company focusing on the development and industrialization of cell therapies and antibody drugs. Established in 2017, the company has built an international management team with extensive experience in new drug development, clinical research, and commercialization. With a foundation of innovation in developing cell-based drugs and antibody drugs for hematological tumors, the company is expanding into solid tumors and autoimmune diseases. It possesses comprehensive, full-process platform capabilities from early discovery, regulatory submission, and clinical development to commercial production. Its multiple technological platforms include a fully human antibody discovery platform, a high-throughput CAR-T drug optimization platform, a universal CAR technology platform, a manufacturing technology platform, and a clinical translational research platform. Currently, the company has 10 pipeline products at various stages of development. Among them, the most advanced product, CT103A (a fully human BCMA chimeric antigen receptor autologous T-cell injection), is in the late stage of clinical development and has been designated as a "breakthrough therapy" by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA). Another self-developed innovative product, CT120 (a fully human CD19/CD22 dual-target CAR-T cell injection), has entered the clinical research phase for indications including relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory acute B lymphoblastic leukemia (B-ALL) that are CD19/CD22 positive.

With a highly efficient management team, a rich product pipeline, and unique innovation in R&D and business models, IASO Bio is committed to becoming an influential innovative pharmaceutical company in the industry. The company aims to bring truly clinically impactful, market-competitive innovative drugs to patients, opening new treatment pathways and bringing new hope. For more information, please visit the company website: www.iasobio.com or LinkedIn page: IASO Biotherapeutics (驯鹿医疗).