A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
Not Applicable
Completed
- Conditions
- Neuroblastoma
- Registration Number
- NCT01802138
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method T cell count after in vitro expansion up to 13 weeks T cell count after in vitro expansion
Evaluation of safety
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Chongno-gu, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Chongno-gu, Korea, Republic of