CD6-CAR Treg Cells for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with Type 1 diabetes, a condition where the immune system mistakenly attacks insulin-producing cells in the pancreas. The trial uses modified immune cells called Tregs (regulatory T cells) to recognize and calm the immune attack on these vital cells. Participants should have a Type 1 diabetes diagnosis within the past 1-2 years and retain some insulin production ability. The goal is to determine if this approach can help manage the disease and reduce the need for insulin treatment. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
In a previous study, specially modified immune cells called autoCD6-CAR Treg cells showed a promising early safety profile. Researchers found that these cells were generally well-tolerated, with most participants not experiencing severe side effects. Some studies also suggest that these cells can effectively target and reduce harmful immune responses related to type 1 diabetes. Although these findings are encouraging, the research remains in its early stages. More studies are needed to confirm their safety and effectiveness in a larger group of people.12345
Why do researchers think this study treatment might be promising for diabetes?
Unlike the standard diabetes treatments like insulin and oral medications that manage blood sugar levels, autoCD6-CAR Treg cells are designed to tackle the root cause of diabetes by modulating the immune system. These modified Treg cells have the potential to prevent the immune system from attacking insulin-producing cells, which is a key problem in autoimmune forms of diabetes. Researchers are excited about this approach because it targets the disease at its source, potentially offering a more long-lasting and transformative solution.
What evidence suggests that autoCD6-CAR Treg cells might be an effective treatment for type 1 diabetes?
Research has shown that a new type of cell therapy, called autoCD6-CAR Treg cells, may aid in treating type 1 diabetes (T1D). In this trial, participants will receive an I.V. infusion of these specially engineered cells, which target and reduce the immune cells that mistakenly attack the body's insulin-producing cells. Early studies suggest that these cells can protect insulin-producing cells, potentially reducing the need for lifelong insulin use. Tregs, or regulatory T cells, naturally help control the immune system. By modifying them, scientists aim to enhance their effectiveness specifically for T1D. Although this therapy remains under investigation, initial results appear promising for T1D treatment.12356
Who Is on the Research Team?
Matthew Mei, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
I.V. infusion of autoCD6-CAR Treg cells to evaluate safety, tolerability, and feasibility
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in insulin, C-peptide, CGM metrics, and Hb1Ac levels
Safety Monitoring
Monitoring for toxicity, CRS, ICANS, and hyperglycemia/DKA
What Are the Treatments Tested in This Trial?
Interventions
- AutoCD6-CAR Treg cells
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
I.V. infusion of autoCD6-CAR Treg cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Autologous CD6-CAR Treg Cells for Patients With Stage 3 ...
This study is designed to evaluate the safety, tolerability, and feasibility of autoCD6-CAR Tregs as T1D treatment. Currently, the disease is ...
CAR T cell therapy in type 1 diabetes - PMC - NIH
Recent preclinical data have shown auspicious results showcasing the potential of CAR T cells to selectively eliminate autoreactive immune ...
SUN-563 Safety And Efficacy Of Antigen Specific Car Tregs ...
The ability to engineer Tregs with specificity to known autoantigens could enable targeted immune suppression and provide effective treatments.
E cacy and Safety of Regulatory T-cell Therapies in Type 1 ...
Background: Type 1 diabetes mellitus results from autoimmune destruction of pancreatic beta cells, leading to lifelong insulin dependence.
5.
diabetesresearchconnection.org
diabetesresearchconnection.org/projects/re-educating-the-patients-immune-system/A Potential Second Cure for T1D by Re-Educating ...
This project focused on engineering primary human regulatory T cells (Tregs) with a chimeric antigen receptor (CAR) to create a therapy for type 1 diabetes (T1 ...
6.
acrabstracts.org
acrabstracts.org/abstract/a-phase-1-study-of-autologous-car-treg-cells-in-refractory-rheumatoid-arthritis-interim-report-of-safety-and-efficacy/A Phase 1 Study of Autologous CAR-Treg Cells in ...
Conclusion: In this ongoing phase 1 study, Cit-P–targeted CAR-Tregs demonstrate a favorable early safety profile, with preliminary clinical and ...
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