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An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D

RECRUITINGPhase 1/2Sponsored by CRISPR Therapeutics AG
Actively Recruiting
PhasePhase 1/2
SponsorCRISPR Therapeutics AG
Started2023-01-20
Est. completion2025-04
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05565248

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions8

Autoimmune DiseasesDiabetesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesGlucose Metabolism DisordersImmune System DiseasesMetabolic Disease

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