A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

NCT ID: NCT05791201

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2026-05-29

Brief Summary

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The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VX-264

Group Type EXPERIMENTAL

VX-264

Intervention Type DRUG

Allogeneic human stem cell-derived islets.

Interventions

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VX-264

Allogeneic human stem cell-derived islets.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Exclusion Criteria

Prior islet cell transplant, organ transplant, or cell therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UHealth Diabetes Research Institute

Miami, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center Montefiore

Pittsburgh, Pennsylvania, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

University of Alberta, Edmonton

Edmonton, , Canada

Site Status

Montreal Clinical Research Institute

Montreal, , Canada

Site Status

Toronto General Hospital (TGH)

Toronto, , Canada

Site Status

Vancouver General Hospital

Vancouver, , Canada

Site Status

Dresden Center for Islet Transplantation

Dresden, , Germany

Site Status

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Leiden University

Leiden, , Netherlands

Site Status

Hopiteaux Universitaires de Geneve

Geneva, , Switzerland

Site Status

Churchill Hospital

Headington, , United Kingdom

Site Status

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Canada Germany Italy Netherlands Switzerland United Kingdom

Other Identifiers

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2024-515583-32-00

Identifier Type: OTHER

Identifier Source: secondary_id

VX22-264-101

Identifier Type: -

Identifier Source: org_study_id

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