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Feasibility Study of AloCelyvir and Autologous Tumor‑Infiltrating T Lymphocytes in Children and Young Adults with High‑Risk Relapsed/Refractory Neuroblastoma

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What is this study about?

The study looks at children and young adults with advanced, high‑risk relapsed/refractory neuroblastoma, a cancer that starts in nerve tissue and often returns after standard treatment. The experimental approach combines two cell‑based products. The first product, called AloCelyvir, is made from donor bone‑marrow stem cells that have been genetically altered with a virus named ICOVIR-5 and grown in the laboratory before being given by an intravenous (into a vein) infusion. The second product uses the patient’s own tumor‑infiltrating tumor-infiltrating lymphocytes, which are immune cells taken from the tumor, expanded outside the body with the help of three immune‑boosting proteins: interleukin-7, interleukin-15, and interleukin-21. The main purpose of the study is to determine whether the combination of these two cell therapies can be administered safely.

Participants will first receive the stem‑cell product and, after a short interval, the expanded T‑cell product, each as a single intravenous infusion. After each infusion, patients will remain in the hospital for observation and will have regular check‑ups, blood tests, and physical examinations to look for any side effects or problems. The study will continue to follow each participant for several months, recording any changes in the cancer and overall health, with the goal of learning how the treatments are tolerated and whether they show any early signs of benefit.

1 baseline assessments

after enrollment, undergo a series of medical examinations, blood tests, and imaging studies to document the current condition of the neuroblastoma and overall health.

these assessments are used to confirm that the patient meets the study criteria and to establish a reference point for future comparisons.

2 collection of tumor tissue

a sample of tumor tissue is obtained through a scheduled biopsy or surgery.

the tissue is sent to a specialized laboratory where autologous tumor‑infiltrating lymphocytes (tils) are isolated and prepared.

3 manufacturing of study cells

the laboratory expands the patient’s own tils using interleukin‑7, interleukin‑15 and interleukin‑21, creating a cell suspension for injection.

in parallel, allogeneic bone‑marrow‑derived mesenchymal stem cells are transduced with icovir‑5 and expanded to produce alocelyvir.

4 first cell infusion (alocelyvir)

the prepared alocelyvir product is administered intravenously as a bolus injection or infusion.

the exact volume and rate are determined by the study protocol; no specific dose amount is listed in the trial description.

5 observation period after alocelyvir

following the infusion, the patient is monitored for any immediate side effects, including vital signs and laboratory values.

this observation period helps identify any dose‑limiting toxicities, which are the primary safety focus of the trial.

6 second cell infusion (autologous tils)

after the observation period, the expanded autologous tils are administered intravenously as a bolus injection or infusion.

as with alocelyvir, the specific dose and infusion rate follow the study protocol and are not detailed in the provided information.

7 post‑infusion monitoring

the patient continues to be observed for adverse events, with regular checks of vital signs, physical examinations, and laboratory tests.

any side effects are recorded and graded according to standard criteria.

8 follow‑up visits and assessments

periodic clinic visits are scheduled to evaluate the response of the neuroblastoma, using imaging and clinical examinations.

these visits also include safety assessments such as blood work and monitoring for new or ongoing adverse events.

9 final evaluation

at the end of the trial period, a comprehensive assessment is performed to determine overall response, progression‑free survival, and overall survival outcomes.

the results contribute to the study’s objective of establishing the safety and tolerability of the sequential combination of alocelyvir and tils.

Who Can Join the Study?

  • Have neuroblastoma that has relapsed or is refractory (meaning it has come back or did not respond to previous treatments) and no known cure is available.
  • Give written informed consent (and assent if you are old enough) together with your parent or legal guardian to join the study.
  • Weigh at least 3 kg (about 6.6 lb).
  • Be between 1 month and 21 years old.
  • Have at least one tumor spot that can be seen on imaging (scans) or measurable bone‑marrow disease that can be examined under a microscope.
  • Be able to undergo an excisional biopsy to remove a small piece of tumor (about 2 cm × 2 cm) so that TILs (tumor‑infiltrating lymphocytes, a type of immune cell) can be collected.
  • Have a life expectancy longer than 14 weeks (about 3½ months) without the study treatment.
  • If you are a female who could become pregnant, you must have a negative serum or urine pregnancy test within the past 72 hours and agree to use acceptable birth‑control methods during the study and for at least 12 months after the lymphodepleting therapy (a treatment that lowers immune cells).
  • If you are a male who could father a child, you must agree to use condoms during the study and for at least 12 months after the lymphodepleting therapy.
  • Show adequate organ function (normal liver, kidney, heart, and other major organ health) before starting the treatment.

Who Cannot Join the Study?

  • You must not have received any systemic anticancer therapy (cancer‑fighting medicines that affect the whole body) within the last 14 days, or within a time equal to five times the drug’s half‑life (the period it takes for half of the drug to leave your body), whichever is shorter.
  • You cannot have an active infection with hepatitis B, hepatitis C, or HIV (viruses that affect the liver or immune system).
  • You cannot have a primary immunodeficiency (a condition you are born with that makes your immune system weak).
  • You cannot have an active autoimmune disease that requires immunosuppressive therapy (medicines that lower the activity of the immune system).
  • You must not have had a very strong chemotherapy called myeloablative therapy followed by a return of your own blood‑forming stem cells (autologous hematopoietic stem cell rescue) within the past 4 weeks.
  • You cannot have had a stem‑cell transplant from another person (allogeneic stem cell transplantation) within the past 3 months.
  • You must not have received radiotherapy (non‑palliative) (radiation treatment that is not only for comfort) within the last 14 days.
  • You cannot have had major surgery in the past 14 days.
  • You must not have any side‑effects from previous treatment that are Grade 3 toxicity (CTCAE) or higher (moderate to severe problems according to a standard grading system).
  • You cannot have brain tumors that are causing symptoms or that have not been treated (symptomatic or untreated brain metastases). Treated brain metastases may be considered only after special discussion.
  • You must not have had a severe immediate allergic reaction or intolerance to the drugs cyclophosphamide, fludarabine, aldesleukin, or any ingredient (called an excipient) in the lab‑grown immune cells (TILs).
  • You cannot have an active, uncontrolled infection caused by bacteria, viruses, fungi, or parasites.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Haaaniqa Vgzq dnfolsfw Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.07.2026

Trial locations

Investigated Drugs:

Autologous tumor-infiltrating T lymphocytes, ex vivo expanded with interleukin-7, interleukin-15 and interleukin-21 are immune cells that are taken from the child’s own tumor. In the laboratory, these cells are grown with special proteins (interleukin‑7, interleukin‑15, and interleukin‑21) that help them multiply and become more active. After they are expanded, the cells are given back to the patient through an IV infusion. The goal is for these boosted T‑cells to recognize and destroy any remaining cancer cells in the body.

AloCelyvir is a therapy that uses stem cells taken from a donor’s bone marrow. These cells are genetically modified with a harmless virus called icovir‑5, which turns the stem cells into tiny “delivery trucks” that can travel to the tumor and release anti‑cancer signals. After being grown in the lab, the modified stem cells are infused into the patient’s bloodstream. The purpose is to help the immune system fight the neuroblastoma by targeting the cancer from a different angle.

Investigated Diseases:

High‑risk relapsed/refractory neuroblastoma – Neuroblastoma is a cancer that arises from immature nerve‑cell precursors, most often in the adrenal glands or sympathetic nervous system. High‑risk disease shows rapid growth and often spreads to bone marrow, lymph nodes, and distant organs. When it relapses or becomes refractory, the tumor returns or does not respond to standard therapies, leading to continued progression.

Trial ID:
2025-522006-21-00
Protocol code:
ACTIVE
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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