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

Plain Language Summary

Simplified for easier understanding

This first-in-human trial is evaluating a new experimental treatment called VCTX211 for type 1 diabetes (T1D). VCTX211 uses gene-edited cells designed to produce insulin without triggering an immune rejection response — meaning it may not require immunosuppressant drugs. **You may be eligible if...** - You have had a confirmed diagnosis of type 1 diabetes for at least 5 years - Your diabetes management has been stable for at least 3 months **You may NOT be eligible if...** - You have a history of islet cell, kidney, or pancreas transplant - You had 2 or more severe unexplained low blood sugar episodes in the past 6 months - You have a type of diabetes other than type 1 - You took immunosuppressive medications in the past 30 days or need them ongoing - You have previously received gene therapy or a gene-edited cell product Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTVCTX211

CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device


Locations(2)

University of Alberta

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

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NCT05565248


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