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

NCT06674265 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-09

No results posted yet for this study

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

Conditions

  • Neuroblastoma, Recurrent, Refractory
  • Neuroblastoma (NB)
  • Neuroblastoma in Children

Interventions

BIOLOGICAL

Allogenic 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.

Sponsors & Collaborators

  • Royan Institute

    collaborator OTHER_GOV

  • Iran University of Medical Sciences

    collaborator OTHER

  • Marzieh Ebrahimi

    lead INDUSTRY

Principal Investigators

  • Dr. Marzieh Ebrahimi, PhD. in Medical Immunology · Royan Institute

  • Dr. Mohammad Faranoush, Pediatric Oncologist · Iran University of Medical Science

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06674265 on ClinicalTrials.gov