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

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started2026-11-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 17 months later Sep 14, 2026 → Feb 21, 2028
See other at-risk trials from City of Hope Medical Center

Amendment history

2026-10-02
critical
Primary completion pushed: 2026-09-14 → 2028-02-21
Completion pushed: 2026-09-14 → 2028-02-21
2026-07-10
minor
Study Status v5
Start date2026-06-01→2026-09-01
2026-05-11
minor
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2026-05-05
notable
Study Status, Contacts/Locations v3
Trial status changed: Recruiting → Not Yet Recruiting
Study sitesdetails revised at 1 of 1 site
2026-04-27
minor
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2026-04-16
notable
Study Status, Contacts/Locations v1
Recruitment opened
Primary completion moved earlier: 2027-09-14 → 2026-09-14
Completion moved earlier: 2028-09-14 → 2026-09-14
Start date2026-03-01→2026-06-01
Study sites0→1
2026-02-03
minor
Original filing
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.
Trial Details
NCT Number NCT07395050
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Stage 3 Type 1 Diabetes
Enrollment 6 participants
Start Date 2026-11-01
Primary Completion 2028-02-21 (estimated)
Study Completion 2028-02-21 (estimated)
Updated on ClinicalTrials.gov 2026-10-01