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

2026-09-10

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

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)

Facility	City	Region
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
Churchill Hospital	Headington	United Kingdom
Royal Victoria Infirmary	Newcastle upon Tyne	United Kingdom

More Vertex Pharmaceuticals Incorporated trials in the UK

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Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older Active, not recruiting

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Enrolling by invitation

Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) Recruiting

Other trials for the same condition

Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) Recruiting

SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes 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