Allogenic Natural Killer cell therapy in relapsed Neuroblastoma pediatric patients
Phase 1
Recruiting
- Conditions
- euroblastoma.Malignant neoplasm of unspecified part of unspecified adrenal glandC74.90
- Registration Number
- IRCT20201202049568N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Any amount of neuroblastoma tumor cells in the bone marrow that can be seen from at least one aspiration sample
Tumors seen on CT in at least one soft tissue.
Have at least 1 MIBG- lesion with a score of 1-2 Curie
The patient has a life expectancy of at least 12 weeks.
The function of the patients organs must be acceptable.
Patient age from 1 to 15 years
Exclusion Criteria
Active or uncontrollable infection
History of allergies or any hypersensitivity to animal proteins
Heart failure
Serious mental and physical disabilities
Participation in any other clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure tumor response after infusion of expanded activated NK cells. Response will be assessed as defined by Revised International Neuroblastoma Response Criteria 2017. Timepoint: Each 6 month Over 2 years. Method of measurement: Disease status at primary and metastatic soft tissue sites will be assessed using MIBG scans or PET scan as applicable.
- Secondary Outcome Measures
Name Time Method To measure the numbers of infused NK cells in peripheral blood at specific time-points after NK cell infusion. Timepoint: before intervention and 2, 4 , 6 month after intervention. Method of measurement: NK cells will be identified by flow cytometry in peripheral blood and their percentages and absolute numbers will be calculated.