Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06832410

An Efficacy, Safety, and Tolerability Study of VX-880 in Participants 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Kidney Transplant Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto General Hospital - Endocrinology, Toronto, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological/Vaccine

Biological

Infused into the hepatic portal vein.

Other names: Zimislecel, Formerly known as STx-02

Primary outcomes

  1. Proportion of Participants who are Insulin Independent

    Time frame: At 1 year After VX-880 infusion

Secondary outcomes

  1. Proportion of participants who achieve insulin independence and are insulin independent 12 months later

    Time frame: 1 year after achieving insulin independence

  2. Change from Baseline in glycosylated hemoglobin (HbA1c)

    Time frame: Baseline, At 1 year After VX-880 infusion

  3. 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)

  4. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.