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Completed

NCT Number: NCT01802138

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.

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activated T lymphocyte

Biological

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

Other names: Immuncell-LC

Primary outcomes

  1. T cell count after in vitro expansion

    Time frame: up to 13 weeks

    T cell count after in vitro expansion

    Evaluation of safety

Secondary outcomes

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

    Time frame: up to 1 year

    To determine the response rate

    To evaluate 1 yr progression free survival and overall survival

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Mar 1, 2013
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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