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An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D
NCT05565248 · CRISPR Therapeutics
In plain English
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Official title
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)
About this study
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.
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
Study design
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-01-20
Estimated completion: 2025-08
Last updated: 2024-05-23
Interventions
Combination Product: VCTX211
Primary outcomes
- • Incidence of adverse events with causality related to VCTX211 units, the surgical procedures and/or medical interventions required to implant and explant the VCTX211 units. (From implantation up to 12 months post implantation)
- • Assess the clinical efficacy of VCTX211 units via evaluation of C-peptide increase from the baseline. (From implantation up to 12 months post implantation)
Sponsor
CRISPR Therapeutics AG · industry
With: ViaCyte
Contacts & investigators
ContactClinical Trials · contact · MedicalAffairs@crisprtx.com · +1 (877) 214-4634
InvestigatorManasi Jaiman, MD, MPH · study_director, ViaCyte
InvestigatorSandeep Soni, MD · study_director, CRISPR Therapeutics
All locations (2)
University of AlbertaRecruiting
Edmonton, Alberta, Canada
University of British ColumbiaRecruiting
Vancouver, British Columbia, Canada