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

April 7, 2019 updated by: Seoul National University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chongno-gu
      • Seoul, Chongno-gu, Korea, Republic of
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Activated T lymphocyte
intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.
Other Names:
  • Immuncell-LC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell count after in vitro expansion
Time Frame: up to 13 weeks

T cell count after in vitro expansion

Evaluation of safety
up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILC_IIT_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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