NCT05210530

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

3 active sites

Status
completed

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

December 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

December 7, 2021

Last Update Submit

June 23, 2023

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 (1)

  • Incidence of adverse events with causality related to VCTX210A units and/or the surgical procedures required to implant and explant the VCTX210A units.

    From implantation up to 6 months post implantation

Secondary Outcomes (6)

  • Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host innate immune cells within the graft.

    From implantation up to 6 months post implantation

  • Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host adaptive immune cells within the graft.

    From implantation up to 6 months post implantation

  • Incidence of new alloreactive antibodies found in the blood of patients post implantation.

    From implantation up to 6 months post implantation

  • Incidence of new autoreactive antibodies found in the blood of patients post implantation.

    From implantation up to 6 months post implantation

  • The percentage of viable graft cells per unit using immunohistochemical staining.

    From implantation up to 6 months post implantation

  • +1 more secondary outcomes

Study Arms (1)

VCTX210A combination product

EXPERIMENTAL

Up to seven (7) units will be implanted

Combination Product: VCTX210A unit

Interventions

VCTX210A unitCOMBINATION_PRODUCT

CRISPR-Cas9 genetically modified PEC210A cells loaded into a delivery device

VCTX210A combination product

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, optimized diabetic 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 (3)

University of Alberta

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

LMC Manna

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Ellis CE, Mojibian M, Ida S, Fung VCW, Skovso S, McIver E, O'Dwyer S, Webber TD, Braam MJS, Saber N, Sasaki S, Lynn FC, Kieffer TJ, Levings MK. Human A2-CAR T Cells Reject HLA-A2 + Human Islets Transplanted Into Mice Without Inducing Graft-versus-host Disease. Transplantation. 2023 Sep 1;107(9):e222-e233. doi: 10.1097/TP.0000000000004709. Epub 2023 Aug 21.

    PMID: 37528526DERIVED

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

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

December 7, 2021

First Posted

January 27, 2022

Study Start

January 24, 2022

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

CA(3)