recurrent and refractory of high-risk neuroblastoma. adrenal gland, Cancer, neuroblastoma
Conditions
Interventions
Intervention 1: A specific number of cells for each patient, based on the patients weight (5×10^6 cells/kg), are thawed and prepared in a volume of 1×10^6 cells/ml for each injection. For patients who
Sponsors
Kian immune cell company
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Inclusion criteria
Inclusion criteria: 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. Measurable residual disease based on imaging findings using Curie scoring or MIBG or PET imaging criteria (1: measurable tumor of at least 10 mm in one dimension on MRI or CT scan with positive uptake on I-123 MIBG scan (“MIBG avid”) or 2) increased FDG uptake on 18F-FDG PET-CT or PET-MRI (“PET avid”)).
Exclusion criteria
Exclusion criteria: 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 Grade 2. Insufficient cardiovascular functionShortening fraction Grade 2 (4 to 6 stools per day). Significant illness not covered by exclusion criteria but interfering with the study process or increasing the intensity of treatment with NK cells. Participation in another clinical trial. Severe impairment of major organ functions, such as renal, cardiac, hepatic, neurological, pulmonary, or gastrointestinal toxicity above Grade 2 according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 5.0 (CTC v5.0). Inability to comply with protocol requirements. Lack of confirmed and signed consent by the patient's guardians. Evidence of HIV disease (Human Immunodeficiency Virus) or positive serology for HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety. Timepoint: After each injection to next injection and 2 weeks after last injection. Method of measurement: Using CTCAEs (Common Terminology Criteria for Adverse Events) checklist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate comparison between control and intervention groups. Timepoint: 6 and 12 months after the last injection. Method of measurement: MRI and MIBG or PET scan.;Overall survival and progression-free survival. Timepoint: up to 12 months after the last injection. Method of measurement: using Kaplan-Meier method.;Alteration in bone marrow sample. Timepoint: 12 months after the last injection. Method of measurement: Bone marrow aspiration and H&E staining. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMobina Ghasemi
Kian immune cell
Outcome results
None listed