A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma

Not Applicable

Completed

• Conditions: Neuroblastoma
• Interventions: Biological: Activated T lymphocyte

• 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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-03-01
• Primary Completion: 2016-06
• Study Completion: 2018-10-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activated T-lymphocyte	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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration.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.

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