RecruitingPhase 1NCT06674265

Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma

Evaluation of Safety and Efficacy Evaluation Post Intravenous Infusion of Activated NK Cells in Recurrent and Refractory High-risk Neuroblastoma Patients


Sponsor

Marzieh Ebrahimi

Enrollment

10 participants

Start Date

Nov 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory/recurrent high-risk neuroblastoma. Is the injection of allogenic nk cells safe in patients with R/R high-risk neuroblastoma? Is the injection of allogenic nk cells effective in patients with R/R high-risk neuroblastoma? We will compare the NK cell administration group with a control group that receives conventional treatment to determine whether the intervention is safe and effective


Eligibility

Min Age: 2 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether infusions of natural killer (NK) cells — immune cells taken from healthy donors — can safely and effectively fight neuroblastoma (a type of childhood cancer) that has stopped responding to standard treatments. **You may be eligible if...** - You have high-risk neuroblastoma that did not respond to standard induction chemotherapy (at least 4 cycles) - Your cancer has relapsed or progressed after a stem cell transplant or aggressive therapy - Your cancer is confirmed by pathology and/or bone marrow testing - You have measurable disease on imaging scans - Your expected survival is at least 6 months **You may NOT be eligible if...** - Your overall health and organ function are too poor to tolerate the treatment - You have an active serious infection or other condition that would interfere with treatment - You do not have measurable residual disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogenic NK cells infusion

Natural Killer (NK) cells are extracted from a healthy donor through apheresis and processed in a clean room using the CLINIMACS device. After quality assessment, these cells are stored at -198°C until needed. When required, the cells are thawed, washed, and evaluated for viability and sterility before being administered to the patient at a dosage of 5 × 10\^6 cells per kilogram of body weight. Two further injections may be considered based on the patient's response and confirmed improvement via MRI MIBG. Injections are scheduled seven to ten days after each chemotherapy course according to the standard treatment protocol.


Locations(1)

Rasoul Akram Hospital

Tehran, Iran

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NCT06674265


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