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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuroblastoma

Intervention / Treatment
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* Biological: Activated T lymphocyte


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated T-lymphocyte<br>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<br>* intravenous dripping of 200 ml (10^9 2*10^10 lymphocytes) for 1 hour.<br>* Other names: Immuncell-LC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell count after in vitro expansion | 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 | To determine the response rate To evaluate 1 yr progression free survival and overall survival | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory/relapsed neuroblastoma patients