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

Seoul National University

Status: Completed

Conditions: Neuroblastoma

Treatments: Biological: Activated T lymphocyte

Study type: Interventional

Funder types: Other

Identifiers

NCT01802138

ILC_IIT_03

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Activated T-lymphocyte

Experimental group

Description:

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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration.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

Treatment:

Biological: Activated T lymphocyte