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

Phase 1

Completed

• Conditions: Metabolic Disease; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Immune System Diseases; Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases
• Interventions: Combination Product: VCTX210A unit

• Registration Number: NCT05210530
• Lead Sponsor: CRISPR Therapeutics AG

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-01-18
• Study Start: 2022-01-24
• Study First Posted: 2022-01-27
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VCTX210A combination product	VCTX210A unit	Up to seven (7) units will be implanted

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The percentage of graft cells per unit that have differentiated into endocrine/beta cells as determined by immunohistochemical staining.	From implantation up to 6 months post implantation
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

Trial Locations

Locations (3)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

LMC Manna; 🇨🇦 Toronto, Ontario, Canada