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Testing the Safety of Dendritic Cell and CAR-T Cell Combination Therapy in Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma

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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 studying a condition called diffuse intrinsic pontine glioma, which is a type of brain tumor that occurs in a specific area of the brainstem called the pons. The study involves a combination of three different treatments. The first treatment is DIPG-DC, which consists of special immune cells called dendritic cells that are prepared from the patient's own body. The second treatment is DIPG-lysate, which is material derived from tumor cells that is used to activate the dendritic cells. The third treatment is ARI0008, which consists of the patient's own immune cells called T lymphocytes that have been modified to recognize and attack tumor cells that have a specific target called interleukin-13 receptor alpha 2. The dendritic cells are given as injections under the skin, while the modified T cells are delivered directly into the fluid-filled spaces of the brain through a device called an Ommaya reservoir.

The purpose of this study is to evaluate the safety of using this combination of treatments for the first time in humans. Before receiving these treatments, patients will have completed standard radiation therapy for their condition. The study will involve collecting some of the patient's blood cells through a process called leukapheresis, which are then modified in a laboratory. The dendritic cells will be prepared and given to the patient first through skin injections, and then the modified T cells will be administered into the brain fluid system. Throughout the study, patients will be monitored closely for any side effects or complications that may occur.

The study will also look at how well patients tolerate the full treatment regimen and whether they are able to receive all planned doses of both the dendritic cells and the modified T cells. Doctors will track how the immune system responds to the treatment by examining blood and spinal fluid samples at different time points. They will also monitor the tumor using imaging scans and assess how patients are functioning in their daily lives. The study will follow patients to see how long they survive and how long they live without their disease getting worse, comparing these results to information from other patients who received standard treatment.

The research process

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

  1. Step 1

    Completion of radiation therapy

    Before receiving the trial treatment, radiation therapy must be completed. This is the standard treatment for diffuse intrinsic pontine glioma (a type of brain tumor located in the brainstem).

    The radiation therapy consists of a total dose of 54 to 60 Gy, delivered in small daily doses of 1.8 to 2.2 Gy per session.

  2. Step 2

    Placement of Ommaya reservoir

    An Ommaya reservoir with an intraventricular catheter will be placed. This is a small device surgically implanted under the scalp that connects to a thin tube inserted into the fluid-filled spaces of the brain.

    This device allows medications to be delivered directly into the brain fluid without repeated needle insertions.

  3. Step 3

    Collection of blood cells

    A procedure called leukapheresis will be performed to collect white blood cells from the bloodstream.

    During this procedure, blood is drawn through a vein, white blood cells are separated and collected, and the remaining blood is returned to the body.

    These collected cells will be used to prepare the treatments administered later in the trial.

  4. Step 4

    Administration of dendritic cell vaccine

    The first treatment involves receiving dendritic cell immunization called DIPG-DC. These are specialized immune cells prepared from the collected white blood cells and combined with DIPG-lysate, which is material derived from tumor cells.

    The DIPG-DC vaccine is administered as an intradermal injection, meaning it is injected into the skin.

    The DIPG-lysate is also administered as an intradermal injection.

    The exact schedule and number of administrations will be determined according to the treatment protocol.

  5. Step 5

    Administration of CAR-T cells

    Following the dendritic cell treatment, ARI0008 will be administered. This is a type of CAR-T cell therapy, which consists of the collected white blood cells that have been modified in the laboratory to recognize and attack tumor cells that have a specific marker called IL13Ra2.

    ARI0008 is administered as a suspension for injection through intrathecal use, meaning it is delivered directly into the brain fluid through the previously placed Ommaya reservoir.

    The exact dosage and timing of administration will follow the treatment protocol.

  6. Step 6

    Monitoring and follow-up assessments

    Throughout the trial, regular monitoring will be conducted to assess safety and response to treatment.

    Blood samples and cerebrospinal fluid (the fluid surrounding the brain and spinal cord) samples will be collected according to a predetermined schedule to evaluate the immune response and the presence of the modified cells.

    Brain imaging studies will be performed to evaluate any changes in the tumor according to RAPNO criteria, which are standardized guidelines for assessing brain tumors in children.

    Neurological examinations and assessments of daily functioning will be conducted, including questionnaires to evaluate quality of life.

    Any side effects or adverse reactions will be monitored and recorded throughout the treatment period and follow-up.

  7. Step 7

    Long-term follow-up

    After completing the treatment regimen, continued monitoring will occur to assess long-term outcomes.

    This includes ongoing evaluation of survival, disease progression, and any delayed side effects.

    Regular medical appointments and imaging studies will be scheduled according to the follow-up protocol.

Who can join the trial?

11 criteria

  • You or your legal representative must sign a written informed consent form. If you are 12 years old or older, you must also sign an informed assent form.
  • You must be suitable for placement of an Ommaya reservoir, which is a small device placed under the scalp with a tube that goes into the fluid-filled spaces of the brain to deliver treatment.
  • If you are able to have children, you must use a highly effective birth control method during the study.
  • You must have a newly diagnosed diffuse intrinsic pontine glioma (a type of brain tumor located in a part of the brainstem called the pons) confirmed by clinical examination and imaging scans, or by tissue examination. If a tissue sample was taken, it must show a specific change called K27M mutation.
  • You must have already completed radiotherapy (treatment using high-energy rays) before starting this trial treatment. The radiotherapy should have been 54 to 60 Gy delivered in small doses of 1.8 to 2.2 Gy per session.
  • You must be between 3 and 24 years old.
  • Your Lansky performance score must be 50% or higher if you are under 16 years old. This score measures how well you can perform daily activities. If you are 16 years or older, your Karnofsky score must be 50% or higher, which also measures your ability to carry out daily tasks.
  • Your expected survival time must be greater than 12 weeks.
  • Your bone marrow (the soft tissue inside bones that makes blood cells) must be working well enough. This means you need at least 1,000 neutrophils (a type of white blood cell that fights infection) per microliter of blood, at least 100,000 platelets (cells that help blood clot) per microliter without needing transfusions, and at least 8 grams of hemoglobin (protein in red blood cells that carries oxygen) per deciliter, even if you need blood transfusions.
  • Your liver and kidneys must be working normally.
  • You must have suitable veins that allow for a procedure called leukapheresis, which is a process to collect white blood cells from your blood.

Who cannot join the trial?

12 criteria

  • The patient has a disease or condition other than diffuse intrinsic pontine glioma, which is a specific type of brain tumor located in the brainstem area called the pons
  • The patient's diffuse intrinsic pontine glioma was diagnosed in the past and is not a new diagnosis
  • The patient does not meet the required age range for participation in this study
  • The patient has active infections that could interfere with the treatment or make it unsafe
  • The patient has severe problems with major organs such as the heart, liver, or kidneys that would make the treatment unsafe
  • The patient has received previous treatments that may interfere with this study's experimental therapy
  • The patient has conditions affecting the immune system, which is the body's natural defense system against disease, that could make the treatment ineffective or unsafe
  • The patient is allergic to any components used in the study treatment
  • The patient is unable to undergo the required medical procedures, including placement of a device to deliver medication into the brain
  • The patient has bleeding disorders or problems with blood clotting that could make procedures unsafe
  • The patient is participating in another clinical trial that conflicts with this study
  • Female patients who are pregnant or breastfeeding cannot participate
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Investigated drugs

  • DIPG-DC

    is a dendritic cell immunization treatment. Dendritic cells are special immune cells taken from the patient's body that are trained in a laboratory to recognize cancer. In this trial, these cells are pulsed with tumor lysate, which means they are exposed to proteins from tumor cells to help them learn to identify and attack the cancer.

  • DIPG-lysate

    is a mixture made from proteins of tumor cells. It is created from a collection of 8 different tumor cell lines that have a specific mutation called K27M. This lysate is used to train the dendritic cells to recognize the tumor so the immune system can fight it better.

  • ARI0008

    is a type of CAR-T cell therapy that targets a protein called IL13Ra2 found on tumor cells. CAR-T cells are the patient's own immune cells that have been modified in a laboratory to better recognize and destroy cancer cells. These modified cells are given directly into the fluid-filled spaces of the brain to help fight the tumor.

What is already known about the treatment

  • DIPG-DC (Dendritic Cell Immunization)

    This is an experimental cancer treatment currently being tested in clinical trials for patients newly diagnosed with diffuse intrinsic pontine glioma (DIPG), a rare and aggressive brain tumor. The therapy involves taking special immune cells called dendritic cells from the patient, training them to recognize cancer by exposing them to proteins from DIPG tumor cells, and then injecting them back into the patient to stimulate the immune system to attack the tumor. This investigational treatment works by teaching the body's own immune system to identify and destroy cancer cells that have a specific mutation called K27M, which is commonly found in DIPG tumors.

  • ARI0008 (CAR-T cells targeting IL13Ra2)

    This is an experimental immunotherapy currently under investigation in clinical trials for treating newly diagnosed diffuse intrinsic pontine glioma (DIPG), a serious type of brain tumor in children. The treatment involves collecting immune cells called T cells from the patient, genetically modifying them in a laboratory to recognize a specific protein called IL13Ra2 that is found on the surface of DIPG cancer cells, and then delivering these modified cells directly into the fluid-filled spaces of the brain through a procedure called intraventricular administration. Once inside the brain, these engineered cells seek out and destroy tumor cells that display the IL13Ra2 marker, offering a targeted approach to fighting this difficult-to-treat cancer.

Investigated diseases

Diffuse Intrinsic Pontine Glioma – Diffuse intrinsic pontine glioma is a rare type of brain tumor that develops in the brainstem, specifically in an area called the pons. This tumor grows within the normal tissue of the pons rather than forming a distinct mass that can be easily separated from healthy brain tissue. The disease primarily affects children, typically between the ages of 5 and 10 years. As the tumor grows, it interferes with vital functions controlled by the brainstem, including breathing, heart rate, and blood pressure. Patients commonly experience problems with eye movement, facial weakness, difficulty swallowing, and loss of balance and coordination. The tumor spreads throughout the pons in a diffuse pattern, making it intertwined with critical brain structures.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514052-32-00Protocol codeFSJD-DIPG-DC-CARTEstimated enrolment15 patientsSponsorFundacio Sant Joan De Deu

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