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

NCT06832410 | Recruiting Phase 3 FDA Drug

• 1 other identifier: VX23-880-102
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Type 1 Diabetes; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants who are Insulin Independent

  At 1 year After VX-880 infusion

Secondary Outcomes (4)

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

  1 year after achieving insulin independence

• Change from Baseline in glycosylated hemoglobin (HbA1c)

  Baseline, At 1 year After VX-880 infusion

• Proportion of Participants who Maintain Insulin Independence for at least 1 year

  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)

  From Signing of informed consent to End of Study (up to 2 years)

Study Arms (1)

VX-880

EXPERIMENTAL

Biological: Biological/Vaccine

Interventions

Biological/Vaccine BIOLOGICAL

Infused into the hepatic portal vein.

Also known as: Zimislecel, Formerly known as STx-02

VX-880

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (7)

Perelman Center for Advanced Medicine - Endocrinology

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Montefiore Clinical and Translational Research Center - Endocrinology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UW University Hospital - Endocrinology

Madison, Wisconsin, 53792, United States

RECRUITING

Toronto General Hospital - Endocrinology

Toronto, Canada

RECRUITING

Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

Vancouver, Canada

RECRUITING

King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology

Riyadh, Saudi Arabia

RECRUITING

King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Biological Products; Vaccines

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 17, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); SA (2); CA (2)