Recruiting at 7 sites Phase 3 Type 1 Diabetes

Type 1 Diabetes study: Biological/Vaccine

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

ClinicalTrials.gov ID: NCT06832410

What this study is testing

What is Zimislecel?

This is an investigational biological treatment being studied for people with Type 1 Diabetes who have had a kidney transplant.

Also referred to as STx-02.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to see if the drug VX-880 works well, is safe, and is easy to take for people with Type 1 diabetes and a kidney transplant.
Who it's for
The study is looking for adults with Type 1 diabetes who have received a kidney transplant.
What's involved
Participants will take the study drug VX-880 and visit the clinic for checkups and tests to monitor their health.
Time commitment
The source text does not specify the total duration or the number of required visits.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join 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 Key

You likely can't join if

  • Prior islet cell transplant, organ transplant (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the...
  • Participants had \>1 kidney transplant procedure Other protocol defined Inclusion/Exclusion criteria may apply.

The study team makes the final eligibility decision.

Where it is enrolling

  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Madison, Wisconsin, United States
  • Toronto, Canada
  • Vancouver, Canada
  • Riyadh, Saudi Arabia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Philadelphia, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States; Madison, Wisconsin, United States; Toronto, Canada; Vancouver, Canada; Riyadh, Saudi Arabia. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.