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

NCT01802138 | Completed

• 1 other identifier: ILC_IIT_03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma

Keywords

refractory/relapsed neuroblastoma patients

Outcome Measures

Primary Outcomes (1)

• T cell count after in vitro expansion

  T cell count after in vitro expansion Evaluation of safety

  up to 13 weeks

Secondary Outcomes (1)

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

  up to 1 year

Study Arms (1)

Activated T-lymphocyte

EXPERIMENTAL

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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration.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

Interventions

Activated T lymphocyte BIOLOGICAL

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

Also known as: Immuncell-LC

Activated T-lymphocyte

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Location

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: October 31, 2018
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

KR (1)