An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D

  • STATUS
    Recruiting
  • End date
    Dec 19, 2022
  • participants needed
    10
  • sponsor
    CRISPR Therapeutics AG
Updated on 19 April 2022
treatment regimen

Summary

This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of VCTX210A combination product in patients with T1D

Description

VCTX210A combination product (unit) comprises 2 components: (1) allogeneic pancreatic endoderm cells (PEC210A) genetically modified using Clustered 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 the PEC210A cells.

Details
Condition Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
Treatment VCTX210A unit
Clinical Study IdentifierNCT05210530
SponsorCRISPR Therapeutics AG
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of T1D for a minimum of 5 years
Stable, optimized diabetic 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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