Study on the Safety and Effects of VX-264 for Patients with Type 1 Diabetes

2 1 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Type 1 Diabetes, a condition where the body cannot produce insulin, a hormone needed to control blood sugar levels. The treatment being tested is called the VX-264 Implant, which is a type of cell therapy. This implant is designed to help the body manage blood sugar levels by using a special device called the human channel array device (HCAD). The HCAD is an implantable device that protects the cells from being attacked by the immune system and helps them receive nutrients and oxygen.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the VX-264 Implant in people with Type 1 Diabetes. Participants in the study will receive the implant, and researchers will monitor how well it works and how the body responds to it. The study will be conducted in different parts, with each part focusing on different aspects of the treatment, such as safety and how well it helps the body produce insulin.

Throughout the study, participants will undergo various assessments to ensure their safety and to measure the treatment’s effects. These assessments may include checking vital signs, conducting imaging tests like MRI or ultrasound, and evaluating blood sugar levels. The study aims to provide valuable information about the potential of the VX-264 Implant as a treatment option for people with Type 1 Diabetes.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, procedures, and potential risks and benefits.

Eligibility criteria include being between 18 and 65 years old, having a specific range of HbA1c levels, and a history of Type 1 Diabetes Mellitus (T1D) with insulin dependence for at least 5 years.

2 implantation of VX-264

The participant will receive the VX-264 Implant, which is administered through a procedure called implantation.

This step involves placing the VX-264 units into the body, which is designed to help manage Type 1 Diabetes.

3 monitoring and assessments

Participants will undergo regular monitoring to evaluate the safety and tolerability of the VX-264 Implant.

Assessments include clinical laboratory tests, vital signs checks, and imaging assessments such as ultrasound and magnetic resonance imaging.

4 evaluation of VX-264 function

The function of the VX-264 Implant will be evaluated through various tests, including measuring changes in C-peptide levels during a meal test.

The goal is to assess how well the implant is working in managing blood sugar levels.

5 follow-up and data collection

Participants will continue to be monitored over time to collect data on the implant’s effectiveness and any changes in insulin requirements.

The study aims to observe changes in metabolic control, including HbA1c values and glucose monitoring results.

6 completion of the study

The study is expected to conclude by March 30, 2027.

Participants will have a final assessment to evaluate the long-term effects and outcomes of the VX-264 Implant.

Who Can Join the Study?

Participants must be between 18 and 65 years old, including both ages, at the time they first agree to join the study.
Participants should have a blood test result called HbA1c between 6.0% and 9.5%. This test shows the average blood sugar level over the past 2 to 3 months.
Participants need to have a history and lab results confirming Type 1 Diabetes (T1D). This includes needing insulin for at least 5 years and having a low level of a substance called C-peptide during a special test called MMTT.
Participants must have been using a Continuous Glucose Monitor (CGM) for at least 4 weeks before the study starts and agree to use only the CGM provided by the study during the entire study period.
Participants should have a body size that can support the placement of the planned number of study devices called VX-264 units.

Who Cannot Join the Study?

Patients who have a different type of diabetes other than Type 1 Diabetes cannot participate. Type 1 Diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate. This means they must be able to attend all required visits and follow instructions given by the study team.
Patients who have any other medical conditions that might interfere with the study cannot participate. This includes conditions that could affect the safety or results of the study.
Patients who are pregnant or planning to become pregnant during the study cannot participate. This is to ensure the safety of both the mother and the unborn child.
Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference with the results of either study.
Patients who have a history of allergic reactions to any of the study medications cannot participate. This is to prevent any potential allergic reactions during the study.
Patients who have a history of substance abuse or alcohol abuse cannot participate. This is to ensure that the study results are not affected by these factors.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l.	Palermo	Italy
Lesni Udextfpnuxyf Mmwkkfy Cddcnfr (fvxup	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	13.10.2023
Italy	Not recruiting	13.10.2023
The Netherlands	Not recruiting	13.10.2023

Trial locations

Investigated drugs:

Vx-264

VX-264 is an investigational medication being studied for its potential to help people with Type 1 Diabetes Mellitus. The trial aims to assess how safe and tolerable this medication is for patients, as well as how well it functions in managing the condition. The study is divided into different parts to evaluate these aspects thoroughly.

Investigated diseases:

Diabetes mellitus

Type 1 Diabetes Mellitus – Type 1 Diabetes Mellitus is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in adolescence or early adulthood but can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. This leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. Regular monitoring of blood sugar levels and lifestyle adjustments are crucial for managing this condition.

Trial ID:

2024-515583-32-00

Protocol code:

VX22-264-101

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Safety and Effects of VX-264 for Patients with Type 1 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?