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)

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

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.

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