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

Conditions

• Stage 3 Type 1 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

May 2026

Primary completion

Sep 14, 2026

Completion

Sep 14, 2026

Study Design

Enrollment

6 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: I.V. infusion of autoCD6-CAR Treg cells
  I.V. infusion of autoCD6-CAR Treg cells

Primary Outcome Measure

Toxicity, CRS, ICANS, hyperglycemia/DKA [ Time Frame: till 28 days post investigational drug infusion ]

Central Contacts

• Arthur Riggs Diabetes & Metabolism Research Institute
  866-444-7538
  [email protected]

Locations (1)

Find similar trials in Duarte, CA