RecruitingRare disease

A study to evaluate the safety and effectiveness of QEL-005 in patients with diffuse cutaneous systemic sclerosis and difficult to treat rheumatoid arthritis

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This study aims to determine the safety and tolerability of QEL-005. The research focuses on two conditions: diffuse cutaneous systemic sclerosis, an autoimmune disease where the skin and internal organs become thick and hard, and difficult to treat rheumatoid arthritis, a type of long-term joint inflammation that has not responded well to standard therapies. The treatment being investigated is a form of CAR T-regulatory cell therapy, which involves using a patient's own immune cells that have been specially modified in a laboratory to help regulate the body's immune response.

Participants will receive QEL-005 through an intravenous infusion, which is a method of delivering the medicine directly into a vein. The study is conducted in stages to monitor how the body reacts to the treatment. During this process, health professionals will monitor for any side effects or changes in vital signs and electrocardiogram, a test that records the electrical activity of the heart, to ensure the safety of the procedure.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of therapy
A single dose of QEL-005 is administered via intravenous infusion, which means the medicine is delivered directly into a vein.
QEL-005 is an autologous CAR T-regulatory cell therapy, a type of treatment using your own modified immune cells to target a specific marker called CD19.
Step 2
Safety monitoring
For 14 days following the infusion, monitoring is conducted to identify any dose-limiting toxicities, which are specific side effects that may limit the amount of medicine given.
During the study, regular assessments are performed to check for adverse events (unexpected medical problems), serious adverse events (severe medical problems), and changes in vital signs (such as blood pressure or heart rate).
Safety evaluations include laboratory assessments (blood tests) and an electrocardiogram (ECG), which is a test that records the electrical activity of the heart.

Who can join the trial?

17 criteria

You must be at least 18 years old when you sign the agreement to join the study.
For those with systemic sclerosis, you must have a diagnosis of diffuse cutaneous systemic sclerosis, which is a specific type of autoimmune disease that affects the skin and internal organs.
You must test positive for antinuclear antibodies, which are proteins in the blood that indicate the immune system is attacking the body's own tissues.
You must have not responded well enough to disease modifying anti-rheumatic drugs (DMARDs), which are medications used to slow down the progression of autoimmune diseases.
You must have skin changes measured by a modified Rodnan Skin Score of at least 15, which is a tool doctors use to track how thick or hard the skin has become.
There must be evidence of lung fibrosis, which means scarring in the lung tissue, found through imaging or breathing tests.
You must show signs of active disease based on a standard medical assessment used for this condition.
You must be up to date on all vaccinations according to local health rules.
Your blood counts (haematological), liver function, and kidney function (renal) must be healthy according to medical tests.
You must be willing to receive a flu shot every year.
You must be willing to participate in a 15-year follow-up period to monitor your health long-term.
Your ECOG performance status must be less than 3, which is a scale used to measure how well a person can perform daily activities and manage their symptoms.
You must be able and willing to use a highly effective form of birth control.
You must be taking a stable dose of steroids, which are medications used to reduce inflammation, before starting the study.
For those with difficult to treat rheumatoid arthritis (D2TRA), you must have a diagnosis of rheumatoid arthritis and meet the specific criteria for the "difficult to treat" version of the disease.
You must show signs of active disease through clinical or laboratory results.
You must show evidence of inflammation in your joints, measured by a specific tool called the DAS28 CRP assessment.

Who cannot join the trial?

8 criteria

Having any significant medical condition or abnormal laboratory test results (unusual findings from blood or urine tests) that the doctor believes could make participating in the study unsafe or make it difficult to complete the required tests.
Having a history of, or a concern about, autoimmune diseases (conditions where the body's immune system mistakenly attacks its own healthy cells) other than the specific ones being studied.
Having an active infection (a current illness caused by germs) or a recurrent chronic infection (an infection that keeps coming back and requires medical treatment).
Having an immunodeficiency (a condition where the body's immune system is too weak to fight off germs) or receiving immunoglobulin replacement therapy (treatment where protein medicines are given to help boost the immune system).
A history of, or current infection with, Hepatitis B or C (viruses that affect the liver), tuberculosis (a serious bacterial infection that usually affects the lungs), syphilis (a bacterial infection often spread through sexual contact), or HIV (a virus that attacks the body's immune system).
Having cardiac dysfunction (heart problems or the heart not working correctly) or pulmonary disease (conditions that affect the lungs and breathing).
A history of malignancy (cancer) within the last 5 years.
Taking any prohibited medications (medicines that are not allowed during the study) that cannot be stopped before the screening process begins.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Verified
Otto Von Guericke Universitaet Magdeburg
Magdeburg, Germany
Verified
Universitaetsklinikum Duesseldorf AöR
Duesseldorf, Germany

Trial locations

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Investigated drugs

QEL-005 is a type of cell therapy where a patient's own immune cells are collected and modified in a laboratory to become regulatory T-cells that target a specific protein called CD19. These modified cells are then given back to the patient through an IV infusion to help regulate the immune system in people with certain autoimmune conditions.

What is already known about the treatment

QEL-005 - This experimental therapy is administered as an infusion directly into a vein. Currently being studied in early-stage clinical trials, it is being investigated for its potential to treat hard-to-manage autoimmune conditions like systemic sclerosis and rheumatoid arthritis. This treatment works by using a patient's own specially modified immune cells to help balance the body's immune system and reduce harmful inflammation. It is classified as an autologous CAR T-regulatory cell therapy.

Investigated diseases

Diffuse cutaneous systemic sclerosis
This is a chronic autoimmune condition where the body produces too much collagen. This excess protein causes the skin to become thick and hard. The hardening often starts in the central part of the body and the limbs before spreading. It can also affect internal organs such as the lungs, heart, and digestive tract. As the condition progresses, the skin thickening becomes more widespread and can lead to stiffness in the joints.
Rheumatoid arthritis
This is an inflammatory disorder that primarily affects the joints. The immune system mistakenly attacks the lining of the joints, causing swelling and discomfort. Over time, this inflammation can lead to the gradual wearing down of cartilage and bone. The condition typically affects joints on both sides of the body symmetrically. As it advances, the joints may become deformed or lose their range of motion.