NCT05565248

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jan 2023

Longer than P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

September 30, 2022

Last Update Submit

May 22, 2024

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic DiseaseEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Keywords

Type 1 DiabetesT1DAllogeneicCombination DeviceCRISPR-Cas9Cell TherapyT1DMDiabetesVCTX

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (10)

  • Incidence of adverse events reported in patients implanted with VCTX211 units.

    From implantation up to 12 months post implantation

  • Assess the clinical efficacy of VCTX211 units via evaluation of changes in exogenous insulin use from baseline.

    From implantation up to 12 months post implantation

  • Assess the clinical efficacy of VCTX211 units via evaluation of changes in number of hypoglycemic evens from baseline.

    From implantation up to 12 months post implantation

  • Assess the clinical efficacy of VCTX211 units via evaluation of changes in hemoglobin A1C levels from baseline.

    From implantation up to 12 months post implantation

  • Assess the clinical efficacy of VCTX211 units via evaluation of percentage of time in pre-defined glycemic ranges, as measured by a continuous glucose monitor, from baseline.

    From implantation up to 12 months post implantation

  • +5 more secondary outcomes

Study Arms (1)

VCTX211 unit

EXPERIMENTAL
Combination Product: VCTX211

Interventions

VCTX211COMBINATION_PRODUCT

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

VCTX211 unit

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of T1D for a minimum of 5 years
  • Stable diabetes regimen for at least 3 months prior to enrollment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Manasi Jaiman, MD, MPH

    ViaCyte

    STUDY DIRECTOR

  • Sandeep Soni, MD

    CRISPR Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Clinical Trials

CONTACT

+1 (877) 214-4634MedicalAffairs@crisprtx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

January 20, 2023

Primary Completion

April 1, 2025

Study Completion

August 1, 2025

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

CA(2)