Trials / Recruiting
RecruitingNCT05565248
An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D
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)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- CRISPR Therapeutics AG · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D
Detailed description
VCTX211 combination product (unit) compromises 2 components: (1) allogeneic pancreatic endoderm cells (PEC211) genetically modified using Cluster Regularly Interspaced Short Palindromic Repeats/ CRISPR-associated protein 9 (CRISPR/Cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain PEC211 cells.
Conditions
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Glucose Metabolism Disorders
- Metabolic Disease
- Endocrine System Diseases
- Autoimmune Diseases
- Immune System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VCTX211 | CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device |
Timeline
- Start date
- 2023-01-20
- Primary completion
- 2025-04-01
- Completion
- 2025-08-01
- First posted
- 2022-10-04
- Last updated
- 2024-05-23
Locations
2 sites across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05565248. Inclusion in this directory is not an endorsement.