Evaluating a new combination product for Type 1 Diabetes
An Open-Label, First-in-Human Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With Type 1 Diabetes Mellitus (T1D)
PHASE1; PHASE2 · CRISPR Therapeutics · NCT05565248
This study is testing a new treatment for people with Type 1 Diabetes to see if a special combination of modified cells can help improve their blood sugar control.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | CRISPR Therapeutics (industry) |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT05565248 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter Phase 1/2 study investigates the safety, tolerability, and efficacy of the VCTX211 combination product in individuals with Type 1 Diabetes (T1D). The VCTX211 product consists of genetically modified allogeneic pancreatic endoderm cells designed to evade the immune system, delivered through a specialized device that retains these cells. Participants must have a diagnosis of T1D for at least five years and a stable diabetes regimen prior to enrollment. The study aims to assess how well this innovative approach can improve glucose metabolism in T1D patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Type 1 Diabetes for a minimum of five years who have maintained a stable diabetes regimen.
Not a fit: Patients with a history of islet cell, kidney, or pancreas transplants or those requiring chronic immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option that improves glucose control and reduces the burden of managing Type 1 Diabetes.
How similar studies have performed: While the use of CRISPR technology in diabetes treatment is emerging, this specific combination approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of T1D for a minimum of 5 years * Stable diabetes regimen for at least 3 months prior to enrollment. Exclusion Criteria: * Medical history of islet cell, kidney, and/or pancreas transplant * Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment * Known causes of diabetes other than T1D * Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study * Prior treatment with gene therapy or edited product
Where this trial is running
Edmonton, Alberta and 1 other locations
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
- University of British Columbia — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Study coordinator: Clinical Trials
- Email: MedicalAffairs@crisprtx.com
- Phone: +1 (877) 214-4634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases, Type 1 Diabetes