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Allogeneic Anti-CD7 CAR-T for Type 1 Diabetes

NCT07528105 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528105 on ClinicalTrials.gov