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

Launched by CRISPR THERAPEUTICS AG · Sep 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VCTX211, which is designed to help people with Type 1 Diabetes (T1D). The main goals of the study are to see how safe the treatment is, how well it works, and how well patients can tolerate it. The trial is currently recruiting participants and is open to anyone aged 18 and older who has been diagnosed with T1D for at least 5 years and has been on a stable diabetes treatment for the last 3 months.

To participate in the trial, individuals must not have had any organ transplants, must not have experienced severe low blood sugar episodes recently, and should not be on certain medications that weaken the immune system. If eligible, participants will have the chance to try this new treatment and will be closely monitored by medical professionals throughout the study. This trial is an important step in exploring new options for managing Type 1 Diabetes, and participants will be contributing to valuable research that could benefit others in the future.

Gender

ALL

Eligibility criteria

• 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