Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-16
SponsorMarzieh Ebrahimi
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
High-risk neuroblastoma that is resistant to standard induction therapy based on COG (Children's Oncology Group) criteria (according to INRG criteria and having received at least 4 cycles of multi-drug induction chemotherapy, and not responding to conventional treatments).
Evidence of relapse or progression of neuroblastoma after autologous peripheral blood stem cell transplantation or aggressive therapy.
A minimum life expectancy of 6 months.
Patients must have a pathological diagnosis of neuroblastoma and/or confirmation of tumor cells in the bone marrow with increased urinary catecholamines.
Disqualifiers
Insufficient bone marrow function: Platelet count > 50,000/µL, independent of transfusion (no platelet transfusion within one week). Absolute neutrophil count (ANC) maximum of 500 per microliter. Hemoglobin > 10 grams per deciliter.
Insufficient liver function: Plasma bilirubin level more than 1.5 times the upper limit of normal (ULN). SGPT (ALT) at least three times the upper limit of normal (a level of 45 units per liter is considered the upper limit of normal).
Insufficient kidney function: Creatinine clearance or estimated radioisotope GFR < 70 ml/min/1.73m². Plasma creatinine level more than 1.5 times the upper limit of normal based on age/gender.
Insufficient central nervous system function if seizures are present, entry into the study is not possible and if seizures are not well controlled with anticonvulsant drugs.
Trial design
Design model
Parallel
Treatments tested in this trial
Allogenic NK cells infusion
Biological/VaccineNatural 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.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
NK Cell Infusion Safety
The safety of the treatment is assessed using the Common Terminology Criteria for Adverse Events (CTCAE) checklist.
Time frame
After each injection to next injection and 2 weeks after last injectionSecondary outcomes
1
Response rate comparison between control and intervention groups
The response rate in patients in the control and treatment groups will be assessed and compared using MRI, MIBG, or PET scans.
Time frame
6 months and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marzieh Ebrahimi
Lead sponsor
Kian Immune Cell Company
Sponsor institution
Royan Institute
Collaborator
Iran University of Medical Sciences
Collaborator
Source ClinicalTrials.gov