An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant

March 18, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant

This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Toronto, Canada
        • Recruiting
        • Toronto General Hospital - Endocrinology
      • Vancouver, Canada
        • Recruiting
        • Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Perelman Center for Advanced Medicine - Endocrinology
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Montefiore Clinical and Translational Research Center - Endocrinology
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • UW University Hospital - Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence
  • Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks
  • Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

  • Prior islet cell transplant, organ transplant (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the first 4 weeks
  • Participants had >1 kidney transplant procedure

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-880
Biological: Biological/Vaccine
Infused into the hepatic portal vein.
Other Names:
  • Formerly known as STx-02
  • Zimislecel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants who are Insulin Independent
Time Frame: At 1 year After VX-880 infusion
At 1 year After VX-880 infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in glycosylated hemoglobin (HbA1c)
Time Frame: Baseline, At 1 year After VX-880 infusion
Baseline, At 1 year After VX-880 infusion
Proportion of participants who achieve insulin independence and are insulin independent 12 months later
Time Frame: 1 year after achieving insulin independence
1 year after achieving insulin independence
Proportion of Participants who Maintain Insulin Independence for at least 1 year
Time Frame: From VX-880 infusion to End of Study (up to 2 years)
From VX-880 infusion to End of Study (up to 2 years)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Signing of informed consent to End of Study (up to 2 years)
From Signing of informed consent to End of Study (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

September 17, 2026

Study Completion (Estimated)

September 17, 2027

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX23-880-102
  • EU CT Number (Other Identifier: 2023-503184-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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