Neuroblastoma
Conditions
Keywords
refractory/relapsed neuroblastoma patients
Brief summary
Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.
Interventions
BIOLOGICALActivated T lymphocyte
intravenous dripping of 200 ml (10\^9\ 2\*10\^10 lymphocytes) for 1 hour.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age 21 years or younger * Histologically confirmed neuroblastoma * Progressive disease after standard treatment or relapsed patient * ECOG scale (ECOG-PS) ≤2 * Expected survival at least 3 months
Exclusion criteria
* Patients with autoimmune disease * Patients with immunodeficiency * Other malignancy 5 year prior to this study * Severe organ dysfunction * Severe allergic disease * Severe psychiatric disorder * Pregnancy or lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T cell count after in vitro expansion | up to 13 weeks | T cell count after in vitro expansion Evaluation of safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria | up to 1 year | To determine the response rate To evaluate 1 yr progression free survival and overall survival |
Countries
South Korea
Outcome results
None listed