NCT07395050

Autologous CD6-CAR Treg Cells for Patients With Stage 3 Type 1 Diabetes

A Pilot Study to Evaluate the Safety, Tolerability, and Feasibility of Autologous Anti-CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) in Patients With Stage 3 Type 1 Diabetes

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Type 1 diabetes (T1D) is a persistent and gradually increasing genetic autoimmune disease requiring life-long management. The disease commonly impacts children. However, a quarter of cases are diagnosed in adults. The pancreatic islet beta-cells are responsible for producing insulin, a peptide hormone that is involved in the tight regulation of blood glucose levels. In T1D, the beta-cells are mistakenly destroyed by autoreactive T cells resulting in insulin deficiency and an inability to regulate blood glucose levels. The cause for such an autoimmune reaction to beta-cells is under active investigation. T regulatory cells (Tregs), are specialized immune cells that typically act to control your immune system. Tregs can be modified in the laboratory to recognize and deactivate T1D-causing cells. This process is done by inserting a piece of DNA (the molecules inside cells that carry genetic information and pass it from one generation to the next) into the Tregs. A non-infectious virus called a lentivirus will carry the piece of DNA into the cells that were collected from a donor. Tregs are then grown to large numbers in the laboratory and stored for treatment of T1D. It is not known whether these Tregs cells will treat T1D.

Detailed description

This is a single-center, pilot clinical trial of autologous CD6-targeted chimeric antigen receptor regulatory T cells (autoCD6-CAR Tregs) in patients diagnosed with Type 1 Diabetes (T1D). This study is designed to evaluate the safety, tolerability, and feasibility of autoCD6-CAR Tregs as T1D treatment. Currently, the disease is managed through intensive supportive care. Patients require multiple daily injections or continuous pump delivery of exogenous insulin therapy to manage blood glucose levels. Furthermore, chronic hyperglycemia and hyperglycemic excursions increase the risk of both acute and chronic complications, which can be life-threatening (e.g., severe hypoglycemia, ketoacidosis leading to coma, retinopathy, neuropathy, and nephropathy). Therefore, there is an urgent unmet medical need for curative therapies for patients with T1D. We propose to harness the natural immunomodulatory capacity of regulatory T cells (Tregs) to specifically target pathogenic autoreactive effector T cells (Teffs). CD6 has been implicated in several autoimmune diseases and is highly expressed by activated Teff cells whereas Tregs express little or no CD6. Itolizumab is a first-in-class humanized anti-CD6 monoclonal antibody (mAb) with demonstrated clinical efficacy in psoriasis. Our therapeutic approach is to co-opt the chimeric antigen receptor (CAR) T cell platform to generate autologous Tregs expressing a CD6-targeting CAR (autoCD6-CAR Tregs), which are expected to target activated pathogenic T cells while sparing Tregs in T1D patients.

Conditions

• Stage 3 Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	AutoCD6-CAR Treg cells	The investigational product is an autologous (patient-derived) anti-CD6 chimeric antigen receptor (CD6-CAR) T regulatory cell (Treg) cellular product (CD6-CAR Tregs).

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-09-14
• Completion: 2026-09-14
• First posted: 2026-02-09
• Last updated: 2026-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study