RecruitingPhase 1Phase 2NCT05565248
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)
Sponsor
CRISPR Therapeutics AG
Enrollment
40 participants
Start Date
Jan 20, 2023
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria2
- Diagnosis of T1D for a minimum of 5 years
- Stable diabetes regimen for at least 3 months prior to enrollment.
Exclusion Criteria5
- 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
Interventions
COMBINATION_PRODUCTVCTX211
CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05565248
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