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

NCT ID: NCT01802138

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-10-31

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.

Conditions

Neuroblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration.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.

Group Type: EXPERIMENTAL

Activated T lymphocyte

Intervention Type: BIOLOGICAL

intravenous dripping of 200 ml (10\^9\~2\*10\^10 lymphocytes) for 1 hour.

Interventions

Activated T lymphocyte

intravenous dripping of 200 ml (10\^9\~2\*10\^10 lymphocytes) for 1 hour.

Intervention Type: BIOLOGICAL

Other Intervention Names

Immuncell-LC

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Countries

South Korea

Other Identifiers

ILC_IIT_03

Identifier Type: -

Identifier Source: org_study_id