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A study to assess the safety of RJVA-001 in adults with type 2 diabetes that is not well controlled by current medications.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Type 2 Diabetes, a condition where the body cannot properly regulate blood sugar levels. The research aims to evaluate the safety and tolerability of an experimental treatment called RJVA-001. This treatment consists of a solution for injection containing an adeno-associated virus serotype 9, which is a modified, harmless virus used as a delivery vehicle, carrying the human GCG gene. The goal of using this gene is to help the body produce substances that manage blood sugar.

The administration of RJVA-001 involves a procedure known as endoscopic ultrasound-guided delivery. During this process, a specialized medical tool is used to guide the medication directly into the pancreas, the organ responsible for regulating blood sugar. Participants in the study will receive a single dose of the treatment, and the study will observe how different dose levels affect the body to ensure the process is safe.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of the test substance
The RJVA-001 solution is delivered into the pancreas (an organ behind the stomach that helps control blood sugar).
The delivery is performed using a procedure called endoscopic ultrasound-guided delivery, which uses a specialized tube with an ultrasound device to guide the injection.
Step 2
Safety and health monitoring
safety and tolerability are monitored by checking for any adverse events, which are unintended medical side effects.
laboratory evaluations, such as blood tests, are conducted to track changes in health.
glycemic parameters, which are measurements of blood sugar levels, are monitored to see how the body responds.
continuous glucose monitoring is used to track blood sugar levels automatically over time.
Step 3
Antibody and genetic testing
Tests are performed to measure antibody titers, which are levels of proteins in the blood that the immune system produces to fight specific substances.
The levels of anti-AAV9 and anti-GLP-1 antibodies are tracked.
A digital polymerase chain reaction is used to detect and measure specific genetic material in samples.

Who can join the trial?

16 criteria

You must provide a signed and dated informed consent, which is a document where you agree to participate in the study after understanding all the details.
You must have a calcitonin level that is within the normal range; calcitonin is a hormone produced by the thyroid gland.
The doctor must decide that increasing your current medicine dose or changing your current treatment plan is not a good idea for you.
You must be currently using deferred insulin therapy, which means you are using insulin in a way that is not the primary or most immediate treatment method.
You must be able to handle taking a GLP-1RA, which is a type of medication used to manage blood sugar, either by injection once a week, once a day, or by mouth.
You must agree not to donate blood or semen for at least 1 year after receiving the RJVA-001 injection.
You must agree not to drink alcohol until you have finished the sirolimus taper, which is a process of gradually reducing the amount of the medication sirolimus you are taking.
You must agree not to start any new intense diets, new exercise routines, or any new medications for weight loss during the study.
You must be between 35 and 70 years old.
You must agree to use a reliable form of contraception, which is a method used to prevent pregnancy, during the study and for at least 1 year after the treatment.
You must have a diagnosis of Type 2 Diabetes.
Your body mass index, which is a measurement used to assess if your weight is healthy for your height, must be within the specific range required by the study.
Your fasting plasma glucose (the amount of sugar in your blood after not eating for several hours) and hemoglobin A1c (a test that shows your average blood sugar levels over the past few months) must meet the study's requirements.
You must be taking GLP-1RA medication at the highest dose you can tolerate and may also be taking other allowed medicines to lower blood sugar that are not insulin.
Your C-peptide level, which is a marker used to measure how much insulin your body is naturally producing, must be within the required range.
You must have normal thyroid function, meaning your thyroid gland is working correctly to regulate your body's metabolism.

Who cannot join the trial?

32 criteria

A diagnosis of Type 1 diabetes, monogenic diabetes, latent autoimmune diabetes of adults, or having islet cell autoantibodies, which are proteins in the body that can attack the cells that make insulin.
A history of ketoacidosis, which is a dangerous buildup of acids in the blood caused by diabetes.
A history of significant valvular heart disease (problems with the heart's valves) or aortic stenosis (a narrowing of the heart's aortic valve).
A history of acute coronary syndrome (sudden reduced blood flow to the heart), stroke, or transient ischemic attack (a temporary period of symptoms similar to a stroke).
A history of severe side effects from using GLP-1RA medications that required stopping the medicine.
A history of peripheral vascular disease, which is a circulation problem in the arms or legs.
A history of active malignancy (cancer) or partial remission (cancer that has decreased but is not gone), or a personal or family history of medullary thyroid carcinoma (a specific type of thyroid cancer).
Suspected GI malignancy, which is suspected cancer in the digestive system.
A history of blood dyscrasias (blood disorders) or conditions causing hemolysis (the destruction of red blood cells) or unstable erythrocytes (unhealthy red blood cells).
A history of alcohol or illicit substance abuse.
Taking an investigational drug (a medicine being tested in a study) within a specific timeframe or participating in another clinical trial.
Reasons why a person cannot take systemic steroids (medicines used to reduce inflammation) or sirolimus (an immune-suppressing medicine).
Reasons why a person cannot safely undergo sedation (being calmed or put to sleep) or general anesthesia (being put into a deep sleep for medical procedures).
Being on a weight loss program that is not in the weight maintenance phase, or using GLP-1 weight loss medication.
Having poorly controlled hypertension, which is high blood pressure that is not within a healthy range.
Any other physical or mental condition that the doctor believes could make participation unsafe.
A history of not following a diabetes treatment plan in the last 6 months.
Specific issues found during laboratory tests (blood work) or radiographic exams (medical imaging like X-rays).
A known history of diabetic retinopathy, which is damage to the blood vessels in the eyes caused by diabetes.
An active systemic infection (an infection throughout the body) or being currently treated for a recent infection.
Conditions that require systemic immunomodulation (medicines that change how the immune system works) or having an immune status that makes participation unsafe.
A history of pancreatitis (inflammation of the pancreas) or high levels of fasting triglycerides (a type of fat in the blood).
A family history of hemochromatosis (a condition where the body builds up too much iron) or cystic fibrosis (a genetic disorder affecting the lungs and digestive system).
Reasons why a person cannot undergo an upper gastrointestinal endoscopy (a procedure where a camera is used to look inside the esophagus and stomach).
Symptoms of cholelithiasis (gallstones) or cholecystitis (inflammation of the gallbladder), unless the gallbladder has been surgically removed via cholecystectomy.
Taking certain concomitant medications (other medicines being taken at the same time) that are not allowed.
A history of tuberculosis (a serious bacterial infection that usually affects the lungs).
Receiving a live vaccine within 30 days before the study begins.
A known hypersensitivity or allergy to eggs, milk, wheat, or Spirulina substrates.
Any medical reason why a person cannot receive the infusate (the liquid medicine being delivered through an IV).
A history of hepatic decompensation (liver failure), acute or chronic hepatitis B or C (liver infections), alcoholic hepatitis, autoimmune hepatitis, or portal hypertension (high blood pressure in the vein that carries blood to the liver).
A history of symptomatic heart failure with a reduced or preserved ejection fraction (a measure of how much blood the heart pumps out with each beat).

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

RJVA-001 is a gene therapy designed to help treat type 2 diabetes. It uses a modified, harmless virus to deliver a specific human gene into the pancreas. The goal is to help the body better manage blood sugar levels by addressing the underlying cause of the condition.

ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE

What is already known about the treatment

RJVA-001 - This experimental gene therapy is administered as a solution through a specialized injection guided by ultrasound into the pancreas. Currently being studied in early-stage clinical trials, it aims to treat people with poorly controlled type 2 diabetes. The medication works by using a modified, harmless virus to deliver a specific human gene into pancreatic cells, instructing them to produce more glucagon-like peptide 1 (GLP-1) to help regulate blood sugar. It is classified as a gene therapy product.

Investigated diseases

Type 2 Diabetes - This condition occurs when the body cannot properly use insulin or cannot produce enough of it to maintain healthy blood sugar levels. It often develops gradually over many years. Over time, the body's cells become less responsive to insulin, a state known as insulin resistance. As the condition progresses, the pancreas may struggle to keep up with the demand for insulin. This results in a steady increase in sugar levels within the bloodstream.