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)

Trial ID: NCT05565248

Interventional - Phase 1 - Terminated

This is an open-label, multicenter, Phase 1 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Glucose Metabolism Disorders
• Metabolic Disease
• Endocrine System Diseases
• Autoimmune Diseases
• Immune System Diseases

Interventions

• VCTX211

Eligibility

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

Sponsor

CRISPR Therapeutics AG, ViaCyte

Source: ClinicalTrials.gov

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