A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma|
- T cell count after in vitro expansion [ Time Frame: up to 13 weeks ] [ Designated as safety issue: Yes ]
T cell count after in vitro expansion
Evaluation of safety
- Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
To determine the response rate
To evaluate 1 yr progression free survival and overall survival
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Activated T-lymphocyte
This was designed as a single-center, single group clinical trial, and subjects include patients with refractory refractory/relapsed neuroblastoma.
If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression should be investigated.
Biological: Activated T lymphocyte
intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.
Other Name: Immuncell-LC
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802138
|Contact: Hyoung Jin Kang, MD, Ph.D||82 2 2072 firstname.lastname@example.org|
|Contact: Ji Won Lee, MD||82 2 2072 email@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Chongno-gu, Korea, Republic of|
|Contact: Hyoung Jin Kang, MD, Ph.D 82 2 2072 3304 firstname.lastname@example.org|
|Principal Investigator: Hee Young Shin, MD, Ph.D|