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
City of Hope Medical Center
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.
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…
Eligibility
- Age range
- 18–35 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: Informed Consent and Willingness to Participate * 1\. Documented informed consent of the participant 1. Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant can proceed with lymphodepletion (if applicable) and CAR T cell infusion only after the translated full consent form is signed. * 2\. Willingness to continue into follow-up assessments for up to…
Interventions
- DrugAutoCD6-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).
Location
- City of Hope Medical CenterDuarte, California