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

Seoul National University Hospital6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroblastoma

Interventions

Activated T lymphocyteBIOLOGICAL

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

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Outcomes

Primary Outcomes

T cell count after in vitro expansion

T cell count after in vitro expansion Evaluation of safety

Time frame: up to 13 weeks

Secondary Outcomes

Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria

To determine the response rate To evaluate 1 yr progression free survival and overall survival

Time frame: up to 1 year

Data from ClinicalTrials.gov

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