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


N/A
N/A
21 Years
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

T cell count after in vitro expansion

Outcome Description:

T cell count after in vitro expansion Evaluation of safety

Outcome Time Frame:

up to 13 weeks

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

ILC_IIT_03

NCT ID:

NCT01802138

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

  • Neuroblastoma
  • refractory/relapsed neuroblastoma patients
  • Neuroblastoma

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