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Study on Stem Cell Transplantation and Immunotherapy with Rituximab, Dinutuximab Beta, and Drug Combination for Patients with High-Risk Relapsed Neuroblastoma

Registered drugNo 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 with high-risk neuroblastoma, a type of cancer that occurs in certain types of nerve tissue and is often found in the adrenal glands. The study is designed for patients whose disease has returned or is not responding to initial treatments. The main goal is to evaluate the safety and effectiveness of a special type of stem cell transplant followed by immunotherapy. The stem cell transplant involves using haploidentical stem cells, which are partially matched donor cells, with a process called alfa-beta-CD19+ depletion to prepare the cells for the patient.

After the transplant, patients will receive immunotherapy, which includes an infusion of donor-derived NK cells and an anti-cancer antibody known as anti-GD2 monoclonal antibody. These treatments are given to help the patient's immune system fight the cancer more effectively. The study will monitor various outcomes, including overall survival, how well the donor cells take hold in the patient's body, and any side effects related to the treatments.

The medications and treatments used in this study include Rituximab (also known by code names like CT-P10 and PF-05280586), Dinutuximab beta, Melphalan, Thiotepa, Fludarabine phosphate, and Anti-T lymphocyte immunoglobulin. These are administered as solutions for infusion, meaning they are given directly into the bloodstream through a vein. The study aims to provide valuable information on the potential benefits and risks of these treatments for patients with relapsed or resistant high-risk neuroblastoma.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The initial assessment involves confirming eligibility for the trial. This includes having a diagnosis of high-risk neuroblastoma that has relapsed or progressed after first-line treatment.
Eligibility also requires stabilization of the disease after salvage chemotherapy and the availability of a suitable familial donor for stem cell donation.
Step 2
Stem cell transplantation preparation
Preparation for the transplantation involves the collection of allogeneic peripheral blood-derived haematopoietic stem cells from a suitable donor.
The donor cells are processed to deplete TCR alpha/beta and CD19+ cells, which helps reduce the risk of complications.
Step 3
Conditioning regimen
A conditioning regimen is administered to prepare the body for the stem cell transplant. This includes medications such as melphalan, thiotepa, and fludarabine phosphate, all given intravenously.
The purpose of this regimen is to suppress the immune system and create space for the new stem cells.
Step 4
Stem cell transplantation
The processed stem cells are infused into the bloodstream through an intravenous line.
This step is crucial for rebuilding the blood and immune system with healthy cells.
Step 5
Post-transplantation care
Post-transplantation care includes monitoring for engraftment, which is the process of the new stem cells growing and producing healthy blood cells.
Regular assessments are conducted to check for donor chimerism, which indicates the presence of donor cells in the body.
Step 6
Immunotherapy
Following successful engraftment, immunotherapy is administered. This includes the infusion of donor-derived NK cells and anti-GD2 monoclonal antibodies.
The goal of immunotherapy is to enhance the body's ability to fight cancer cells.
Step 7
Follow-up and monitoring
Regular follow-up visits are scheduled to monitor overall survival, progression-free survival, and any potential side effects or complications.
These visits include assessments of immune reconstitution and the effectiveness of the treatment.

Who can join the trial?

7 criteria

The patient must have a **high-risk neuroblastoma**. This means the cancer is at stage 4 and the patient was older than 12 months when first diagnosed, or the cancer is at stage 2, 3, or 4s with a specific genetic change called **MYCN amplification**.
The cancer must have come back or gotten worse after the first treatment.
The disease must be stable or better after receiving additional chemotherapy, according to the center's clinical practice. **Stable disease** means the cancer has not gotten worse.
There must be a suitable family member who can donate **stem cells**. Stem cells are special cells that can develop into different types of cells in the body. The donor must be a **haploidentical** match, meaning they share some, but not all, genetic markers with the patient.
The family member must be able to donate stem cells from their blood after being given a medicine called **GCSF** (and possibly another medicine called **Plerixafor**) to help increase the number of stem cells in their blood.
The patient's parents or legal guardians must give their informed consent, meaning they understand the study and agree to let the patient participate.
The study is open to both male and female patients.

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with high risk Neuroblastoma that has come back or worsened after the first treatment cannot participate. Neuroblastoma is a type of cancer that usually affects children and starts in certain types of nerve tissue.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups, so if a patient is too young or too old, they may not be eligible.
Patients who do not meet the specific health and medical conditions required for the study cannot participate. This means that if a patient has other health issues that are not part of the study's focus, they may be excluded.
Patients who are not able to follow the study procedures or who cannot give consent to participate cannot be part of the study. This includes understanding what the study involves and agreeing to take part.

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Investigated drugs

Haploidentical Stem Cell Transplantation
is a procedure where stem cells are collected from a donor who is a half-match to the patient, often a family member. These stem cells are then transplanted into the patient to help rebuild their immune system and fight cancer.
Donor-NK Cells Infusion
involves infusing natural killer (NK) cells from a donor into the patient. NK cells are a type of white blood cell that can attack cancer cells and help the patient's immune system to target and destroy the cancer.
Anti-GD2 Monoclonal Antibody
is a type of immunotherapy that uses antibodies designed to target and bind to GD2, a substance found on the surface of neuroblastoma cells. This helps the immune system recognize and attack the cancer cells more effectively.

What is already known about the treatment

Anti-GD2 Monoclonal Antibody – This medication is administered through intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating high-risk neuroblastoma that has relapsed or progressed after initial treatment. The main therapeutic indication is for patients with this specific type of cancer. The mechanism of action involves targeting the GD2 molecule on cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody used in cancer immunotherapy.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and arises from immature nerve cells in various parts of the body. It typically begins in the adrenal glands, which are located on top of the kidneys, but can also develop in the neck, chest, abdomen, or spine. The disease can spread to other areas, including lymph nodes, bones, bone marrow, liver, and skin. In high-risk cases, neuroblastoma may relapse or progress after initial treatment, making it more challenging to manage. Symptoms can vary widely depending on the tumor's location and whether it has spread, often including pain, a lump in the abdomen, or changes in bowel habits. The progression of neuroblastoma can be aggressive, requiring intensive treatment strategies.