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Study of iG-Tregs for Preventing Graft-versus-Host Disease in Adults Undergoing HLA-Matched Sibling Stem Cell Transplantation

InvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on patients undergoing a specific type of stem cell transplant called HLA-matched sibling donor allogeneic hematopoietic cell transplantation. This procedure is used to treat certain blood-related diseases. The study is investigating a new treatment involving special cells known as inducible HLAG+ Regulatory T Cells (iG-Tregs). These cells are given to patients through an injection to help prevent a condition called Graft-versus-Host Disease (GvHD), which can occur after a transplant when the new immune cells attack the patient's body.

The purpose of the study is to determine the safest dose of iG-Tregs and to evaluate their safety when used in patients who have received a transplant from a fully compatible sibling donor. The study will also look at how well these cells work in preventing GvHD. Participants will receive the iG-Tregs injection and will be monitored for any side effects or reactions. The study will compare the results of patients receiving iG-Tregs with those who do not receive this treatment.

Throughout the study, patients will be closely observed for any signs of GvHD and other potential side effects. The study will last for a period of time to ensure that the treatment is safe and effective. The goal is to find a dose that is both safe and effective in preventing GvHD, while also assessing the overall health and recovery of the patients after their transplant.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The initial assessment involves evaluating the patient's health status to ensure eligibility for the trial. This includes checking blood counts, kidney and liver function, and overall health condition.
A negative pregnancy test is required for females of childbearing potential. This test must be repeated if the infusion is delayed by more than 14 days.
Step 2
Preparation for transplantation
The patient must be under continuous cyclosporine (CsA) treatment starting three days before the transplantation. The medication should be maintained at therapeutic levels, which means a concentration greater than 200 ng/ml.
Step 3
Infusion of iG-Tregs
The patient will receive an infusion of iG-Tregs, which are special cells designed to help prevent complications after transplantation. The infusion is administered intravenously, meaning it is given directly into a vein.
The goal is to determine the maximum dose that can be tolerated without causing significant side effects and to evaluate the safety of the infusion.
Step 4
Monitoring for side effects
The patient will be monitored for any immediate side effects of the infusion, such as infusion-related reactions, which are assessed within one hour after the infusion.
Additional monitoring will occur for three weeks to check for any adverse effects, including potential exacerbation of GvHD (graft versus host disease) or infections.
Step 5
Long-term follow-up
The patient will be followed for up to 52 weeks to assess the effectiveness of the iG-Tregs in preventing GvHD and to monitor the overall health status.
The cessation of cyclosporine treatment and any treatment failures, such as the inability to stop cyclosporine by day 150 or disease relapse, will be documented.

Who can join the trial?

20 criteria

The patient must have a **HLA-matched sibling** who will donate cells for the transplant.
The patient must have a **Karnofsky performance status** of 60% or higher. This is a way to measure how well the patient can perform daily activities.
The patient must have **adequate blood and organ function** within 6 weeks of joining the study. This includes:
- **Absolute neutrophil count (ANC)** greater than 1 x 10⁹/L. Neutrophils are a type of white blood cell important for fighting infections.
- **Serum creatinine** less than or equal to 2 mg/dL or **GFR** greater than 40 mL/min/1.73 m². These are measures of kidney function.
- **AST or ALT** less than 3 times the upper limit of normal. These are liver enzymes.
- **Total bilirubin** less than or equal to 2.5 mg/dL, unless the patient has Gilbert’s syndrome, a mild liver condition.
- **Albumin** greater than 2.5 g/dL. Albumin is a protein in the blood.
- **Oxygen saturation** of 92% or higher on room air. This measures how much oxygen is in the blood.
- A **chest X-ray or CT scan** showing no signs of infection.
- No heart disease and an **ejection fraction** greater than 35% on an echocardiogram. This measures how well the heart pumps blood.
- Females of childbearing potential must have a **negative pregnancy test** within 28 days of joining the study and before receiving the treatment.
- Sexually active females and males must agree to use **effective contraception** during the transplant process.
- The patient must be able to understand and be willing to sign an **informed consent form**.
- The patient must be on continuous **cyclosporine (CsA) prophylactic treatment** at therapeutic levels before joining the study. This is a medication to prevent transplant rejection.
- The donor must be a **HLA-matched sibling** who donated the cells for the transplant.
- The donor must be able to understand and be willing to sign an **informed consent form**.
- The donor must be between **16 and 75 years old**.
- The donor must weigh more than **40 kg** and be in good general health.
- If the donor needs to undergo **leukapheresis**, a procedure to collect white blood cells, they must meet certain requirements without prior G-CSF infusion, which is a medication to increase white blood cells.
- Females of childbearing potential who are donors must have a **negative pregnancy test**.

Who cannot join the trial?

5 criteria

Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
Patients who are not undergoing a **hematopoietic stem cell (HSCT) transplantation** from a fully compatible donor sibling are excluded. This is a procedure where a patient receives blood-forming stem cells from a donor.
Patients who are not receiving treatment to prevent or treat **GvHD** (Graft versus Host Disease) are excluded. GvHD is a condition where the donated cells attack the patient's body.
Patients who are not receiving **iG-Tregs injection** from an HLA fully compatible donor after allo-HCT are excluded. iG-Tregs are a type of immune cell used to help prevent GvHD.
Patients who are part of a vulnerable population are excluded. This means individuals who might be at higher risk of harm or exploitation are not eligible.

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Investigated drugs

iG-Tregs: This is a type of cell therapy involving inducible HLAG+ regulatory T cells. These cells are taken from a donor who is a perfect match for the patient. The goal of using these cells is to help prevent a condition called acute graft-versus-host disease (aGvHD), which can occur after a patient receives a stem cell transplant from a donor. The study aims to find out how much of these cells can be safely given to patients and to ensure that the treatment is safe.

IG-TREGS

What is already known about the treatment

Inducible HLAG+ Regulatory T Cells (iG-Tregs) – This medication is administered through injection and is currently being studied in clinical trials for its use in patients undergoing hematopoietic stem cell transplantation (HSCT) from a fully compatible sibling donor. The main therapeutic indication is the prevention and treatment of graft-versus-host disease (GvHD), a common complication following such transplants. At the molecular level, iG-Tregs work by modulating the immune response to reduce the risk of GvHD, leveraging their regulatory function to maintain immune balance. This medication falls under the pharmacological classification of immunotherapy, specifically focusing on enhancing the body's natural regulatory mechanisms to prevent adverse immune reactions.

Investigated diseases

Graft-versus-Host Disease (GvHD) – Graft-versus-Host Disease is a condition that can occur after a stem cell or bone marrow transplant in which the donated cells attack the recipient's body. It typically arises when the donor's immune cells recognize the recipient's tissues as foreign and begin to attack them. GvHD can affect various parts of the body, including the skin, liver, and gastrointestinal tract. The disease is categorized into acute and chronic forms, with acute GvHD usually occurring within the first 100 days post-transplant. Symptoms can range from mild to severe and may include skin rashes, liver dysfunction, and gastrointestinal issues. The progression and severity of GvHD can vary widely among individuals.