Precision Bio Announces Initiation of Phase I Clinical Trial of MC-1-50, a CD19-Directed CAR-T Therapy, for Adults with Refractory Systemic Lupus Erythematosus

Apr 09, 2025 08:15 CST Updated 08:15

Precision Biotech

Gene and Cell Therapy Developer

On April 7, 2025, Chongqing Precision Biotech Co., Ltd. independently developed a CD19-targeted CAR-T cell gene therapy (MC-1-50) The Phase I Clinical Trial Launch Meeting for Adult Refractory Systemic Lupus Erythematosus (SLE)The Second Affiliated Hospital of Zhejiang University School of MedicineSuccessfully held. This conference was organized by the Second Affiliated Hospital of Zhejiang University School of Medicine.Professor Xue Jing, Director of the Rheumatology and Immunology DepartmentLed by him and his team, with the participation of the Precision Biotech Clinical Medicine team and representatives from partner CROs,All parties engaged in technical discussions on execution details such as the design of the trial protocol, subject eligibility criteria, and safety monitoring procedures.

MC-1-50 is based on precision biology.PRIMCAR® Technology PlatformThe targeted CD19 CAR-T candidate product under development is intended for the treatment of refractory SLE patients aged ≥18 years. Previously, the CAR-T therapy developed on this platform has already entered Phase I clinical trials for B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma.The initiation of the SLE indication marks the extension and exploration of its technical pathway into the field of autoimmune diseases.Preclinical studies show that the product, with optimized preparation technology, has technical features such as reducing infusion dosage requirements, decreasing the incidence of treatment-related side effects, and prolonging cell survival time in vivo.

In 2024American Society of Nephrology Kidney Week (ASN Kidney Week)Above, Professor Mao Jianhua's team from the Children's Hospital of Zhejiang University School of Medicine reported exploratory research data on MC-1-50 in pediatric and adolescent SLE: Among 11 treated pediatric and adolescent SLE patients, the SLEDAI-2K scores significantly decreased from baseline after infusion. As of the data cutoff date, all subjects remained in a drug-free remission state. Adverse reactions were mild and quickly improved after symptomatic treatment, with no dose-limiting toxicity events reported.

Director Xue Jing stated that the research team will strictly adhere to the requirements of the clinical trial protocol, advancing the Phase I clinical study of MC-1-50 in an orderly and high-quality manner. Based on data accumulation, they look forward to expanding more research collaborations in the future. The Precision Biotech team emphasized that they will work with all participating units to ensure the standardization of the trial, providing a basis for subsequent evaluation of the therapy's potential treatment value in autoimmune diseases. This kick-off meeting completed the protocol discussion and execution confirmation, and the MC-1-50 adult SLE project has now entered the Phase I clinical trial stage.

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Statement: ContentComeSourceOfficially from Chongqing Precision Biotech Co., Ltd., thisWenPurposeInKnowFor informational purposes only, all content is for reference and does not constitute any advice.