This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
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
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
Single group
Biological/Vaccine
Biological/VaccineInfused into the hepatic portal vein.
Proportion of Participants who are Insulin Independent
Proportion of participants who achieve insulin independence and are insulin independent 12 months later
Change from Baseline in glycosylated hemoglobin (HbA1c)
Proportion of Participants who Maintain Insulin Independence for at least 1 year
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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