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

Purpose

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

Condition

  • Type 1 Diabetes

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

Prior islet cell transplant, organ transplant, or cell therapy

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-264
  • Drug: VX-264
    Allogeneic human stem cell-derived islets.

More Details

Status
Active, not recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact