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Study on CART45RA-NKG2D Cells for Children, Adolescents, and Young Adults with Advanced Sarcoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called , which affects bones and soft tissues. The trial is testing a new treatment using special cells known as . These cells are a form of cell therapy, which means they are designed to help the body’s immune system fight cancer. The treatment is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to determine if this new treatment is safe and feasible for children, adolescents, and young adults with advanced sarcoma. Participants in the study will receive increasing doses of the to see how their bodies respond. The study will also look at how effective the treatment is in reducing the size of the tumors. During the trial, participants will be closely monitored for any side effects and to see how long the treatment stays in their bodies.

The study will take place over several years, and participants will receive regular check-ups to monitor their health and the progress of the treatment. The trial aims to provide valuable information on the potential benefits and risks of using in treating advanced sarcoma, which could lead to new treatment options for patients in the future.

1 enrollment and initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.

A biopsy may be performed to assess the expression of NKG2DL in the tumor. This involves obtaining a tissue sample to ensure the presence of specific markers necessary for the trial.

2 pre-treatment evaluation

A comprehensive evaluation is conducted to ensure recovery from any previous cancer treatments. This includes blood tests to check bone marrow, liver, and kidney function.

The patient’s overall health and life expectancy are assessed to ensure they meet the trial’s requirements.

3 treatment administration

The treatment involves the administration of CART45RA-NKG2D cells through an intravenous infusion. This is a type of therapy where modified immune cells are introduced into the bloodstream to target the cancer cells.

The dosage of the cells is gradually increased to determine the maximum tolerated dose. This process is carefully monitored to ensure safety.

4 monitoring and follow-up

After the infusion, the patient is monitored for any dose-limiting toxicities for up to 28 days. This involves regular check-ups and blood tests to assess the persistence of the NKG2D-CAR T cells in the blood and tumor sites.

The patient’s response to the treatment is evaluated, including any changes in tumor size and the presence of specific markers in the blood.

5 long-term follow-up

The study includes a long-term follow-up period to monitor the patient’s health and any potential side effects. This involves periodic assessments and blood tests.

The trial aims to gather data on the effectiveness and safety of the treatment over an extended period.

Who Can Join the Study?

  • Must be 40 years old or younger at the time of sarcoma recurrence or progression. The sarcoma should have come back or not responded to standard treatments and is considered incurable by these treatments.
  • The patient or their legal representative, parent(s), or guardian must be able to provide written consent to participate in the study.
  • If sexually active, patients must agree to use effective birth control methods for 6 months after receiving the treatment. Male partners should use a condom.
  • The sarcoma samples must show a positive expression of NKG2DL. This means that at least 50% of the tumor cells should show a certain level of this expression. A biopsy, which is a small sample of tissue, will be taken to check this. If the tumor is not easily accessible for a biopsy, archived tissue may be used instead.
  • Patients must have a tumor that can be measured or evaluated by doctors.
  • The tumor must be reachable for direct administration of the treatment in certain cases (only in ARM B).
  • Patients should have a life expectancy of at least 10 weeks, as judged by the main doctor in charge of the study.
  • For patients under 16 years old, a Lansky score of 50 or greater is required. For those 16 years and older, a Karnofsky score of 50 or greater is needed. These scores measure the patient’s ability to perform daily activities.
  • Patients must have recovered from any immediate side effects of previous cancer treatments like chemotherapy or radiotherapy.
  • Patients need to have adequate bone marrow function, which means having a certain level of white blood cells, platelets, and hemoglobin without needing regular blood transfusions.
  • Patients should have normal liver function, with specific levels of bilirubin and liver enzymes, and normal kidney function, with a certain level of creatinine in the blood.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than sarcoma cannot participate. Sarcoma is a type of cancer that starts in certain tissues like bone or muscle.
  • Patients who are not children or young adults are excluded. This study is only for children and young adults.
  • Patients who are not able to safely receive the treatment due to other health conditions or risks are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments recently that might interfere with the study are excluded.
  • Patients who have an active infection or other serious illness that could affect the study results are excluded.
  • Patients who are unable to follow the study procedures or attend follow-up visits are excluded.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Foshmysug Psyx Lz Iravocwtdnkbo Bmqlhzlmz Dlr Hbhdhugz Uxwyzypaqhrok Lc Pch Madrid Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
10.01.2024

Trial locations

NKG2D-CAR Memory T Cells are a type of therapy used in this clinical trial. These are special immune cells that have been modified to better recognize and attack cancer cells. The modification involves adding a chimeric antigen receptor (CAR) that targets a specific protein called NKG2D, which is found on the surface of many cancer cells. This therapy is being tested to see if it is safe and effective for treating children, adolescents, and young adults with advanced sarcoma, a type of cancer.

Investigated diseases:

Sarcoma – Sarcoma is a type of cancer that originates in the connective tissues of the body, such as muscles, fat, blood vessels, nerves, bones, and cartilage. It can occur in any part of the body but is most commonly found in the arms, legs, and trunk. Sarcomas are classified into two main types: soft tissue sarcomas and bone sarcomas, each with various subtypes. The disease often begins as a painless lump or swelling, which may grow over time. As the tumor enlarges, it can press on nearby organs, nerves, or muscles, potentially causing pain or functional impairment. The progression of sarcoma can vary significantly depending on the type, location, and size of the tumor.

Trial ID:
2024-513514-35-00
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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