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

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Activated T lymphocyte
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring refractory/relapsed neuroblastoma patients

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Activated T-lymphocyte

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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration.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

Outcomes

Primary Outcome Measures

T cell count after in vitro expansion
T cell count after in vitro expansion Evaluation of safety

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2013
Last Updated
April 7, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01802138
Brief Title
A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
Official Title
A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
refractory/relapsed neuroblastoma patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activated T-lymphocyte
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Activated T lymphocyte
Other Intervention Name(s)
Immuncell-LC
Intervention Description
intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.
Primary Outcome Measure Information:
Title
T cell count after in vitro expansion
Description
T cell count after in vitro expansion Evaluation of safety
Time Frame
up to 13 weeks
Secondary Outcome Measure Information:
Title
Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria
Description
To determine the response rate To evaluate 1 yr progression free survival and overall survival
Time Frame
up to 1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Chongno-gu
Country
Korea, Republic of

12. IPD Sharing Statement

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

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