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Clinical Trials in the UK / NCT05791201
Active, not recruiting Phase 1/2

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

NCT05791201 · tracked via the Priya Life Science UK tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 1/2
Started
2023-05-16
Last updated
2026-10-09

Condition(s) studied

Type 1 Diabetes

Investigational drug(s) / intervention(s)

VX-264

VX-264: Allogeneic human stem cell-derived islets.

Study summary

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (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, or cell therapy

Primary outcome measure(s)

  • Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From Day 1 up to 24 months
  • Part B: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT) — From Baseline and at Day 90

Trial sites (16)

FacilityCityRegionStatus
UHealth Diabetes Research Institute Miami Florida
University of Chicago Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Hospital of the University of Pennsylvania Philadelphia Pennsylvania
University of Pittsburgh Medical Center Montefiore Pittsburgh Pennsylvania
University of Wisconsin Madison Wisconsin
University of Alberta, Edmonton Edmonton Canada
Montreal Clinical Research Institute Montreal Canada
Toronto General Hospital (TGH) Toronto Canada
Vancouver General Hospital Vancouver Canada
Dresden Center for Islet Transplantation Dresden Germany
IRCCS Ospedale San Raffaele Milan Italy
Leiden University Leiden Netherlands
Hopiteaux Universitaires de Geneve Geneva Switzerland
Royal Victoria Infirmary Newcastle upon Tyne United Kingdom
Churchill Hospital Oxford United Kingdom

More Vertex Pharmaceuticals Incorporated trials in the UK

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) Active, not recruiting
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Transfusion-Dependent β-Thalassemia (TDT) Active, not recruiting
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting
A Long-term Follow-up Study in Participants Who Received CTX001 Enrolling by invitation

Other trials for the same condition

SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes Recruiting
Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05791201 on ClinicalTrials.gov ↗ ← All trials in the UK