Type 1 diabetes mellitus (T1DM) is a T cell-mediated autoimmune disease characterized by autoimmune destruction of pancreatic beta cells, leading to absolute insulin deficiency and lifelong dependence on exogenous insulin. The disease results from loss of immune tolerance, with autoreactive T-cell responses against beta-cell antigens, and is typically associated with islet autoantibodies and insulitis. Although insulin therapy remains the standard of care, it does not correct the underlying autoimmune process. Non-insulin therapeutic strategies for T1DM are mainly directed toward immunomodulation and beta-cell replacement or regeneration. Among immunomodulatory approaches, previous studies have primarily focused on regulation of effector T cells and B cells. Novel immune-based therapies are needed to explore whether modulation of pathogenic immune cell populations may alter disease activity and preserve residual beta-cell function. The purpose of this study is to evaluate the safety, preliminary efficacy, and cellular kinetics of an allogeneic CD7-targeted CAR-T cell injection in participants with early stage T1DM. Participants will receive the investigational product and undergo regular assessments of safety, tolerability, treatment-emergent adverse events, cellular kinetics, glycemic parameters, exogenous insulin requirement, beta-cell function, and immunologic biomarkers. This study is expected to generate preliminary clinical evidence regarding the feasibility and potential therapeutic effects of CD7-targeted CAR-T cell therapy in T1DM.
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Safety: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) in participants with type 1 diabetes mellitus treated with RD13-02.
Timeframe: From the date of signing informed consent to 3 months after CAR-T cell infusion.
Change from baseline in 4-hour MMTT C-peptide AUC at Months 3, 6, and 12.
Timeframe: From baseline to Month 12.