NCT07528105

Allogeneic Anti-CD7 CAR-T for Type 1 Diabetes

A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allogeneic CD7-Targeted CAR-T Cell Injection for the Treatment of Type 1 Diabetes Mellitus

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• T1DM - Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic CD7-Targeted CAR-T Cell Injection	RD13-02 will be administered as a single intravenous infusion using a dose-escalation design. The starting dose is dose level 1 (DL1, 5×10\^7). If no dose-limiting toxicity (DLT) is observed within 28 days after infusion, dose escalation will proceed to dose level 2 (DL2, 1×10\^8). If a DLT is observed, the cohort will be expanded to 6 participants and subsequent dose decisions will follow the standard 3+3 design. The study will be terminated if 2 participants experience DLTs at DL1. If DL1 shows acceptable safety and strong biological activity, the DL2 cohort may be omitted and expansion may proceed at DL1. The planned enrollment is up to 9 participants.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: China