Study Evaluating the Efficacy and Safety With CAR-T for Relapsed or Refractory Neuroblastoma in Children
NCT ID: NCT02919046
Last Updated: 2017-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
22 participants
INTERVENTIONAL
2016-09-30
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm
Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:0 days,the first day,the second day,29 days,30 days Duration:Total five times
GD2-targeted CAR-T cells
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-GD2-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
Interventions
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GD2-targeted CAR-T cells
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-GD2-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
Eligibility Criteria
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Inclusion Criteria
* Relapsed neuroblastoma : Children diagnosed with neuroblastoma who after standard treatment and remission, present lesions again and cannot reach complete remission with surgery.
* Refractory neuroblastoma : ① Untreated patients that do not have to reach completes remission after 4 courses of chemotherapy in accordance with standard regimens nor reach complete remission with surgery. ② High-risk patients : Who have cell genetic variation, such as MYCN amplification or bone marrow metastasis.
2. Relapsed or Refractory Neuroblastoma: Target, of which expression may be intervened , discovered with Immunohistochemistry can be selected (GD2 +) (more than 50% of tumor cells is at least 2+ , adopting anti-GD2-mAb14G2a ).
3. Age: 1\~14 years old of age at the time of enrollment, male or female.
4. Physical condition is good: ECOG score reaches 0 to 2 points.
5. Body weights greater than or equal to 10 kg.
6. White blood cell counts acuity≥ 1.0 x10\^9 / L.
7. Estimated survival times \> 90 days.
8. Voluntary participation, good compliance, can cooperate with the experimental observation and signed an informed consent form.
Exclusion Criteria
2. Uncontrolled infection.
3. HIV infection, hepatitis B or C activity period.
4. Patients who need long-term immunosuppressive therapy (Such as allergies, autoimmune diseases, GVHD, etc.)
5. Combined activity of the central nervous system malignant tumor invasion.
6. Abnormal coagulation function, patients with severe thrombosis.
7. Organ failure
1. Heart：class Ⅱ or above.
2. Liver：class Ⅱ or above( Refer to Classification of Wuhan Conference (1983)).
3. Kidney: The second stage of renal insufficiency or above.
4. Lung: class Ⅱdecreased slightly or above.
5. Brain: The central nervous system transfer or have active lesions.
8. Patients who have participated in other clinical trials or other clinical trials in the past 30 days.
9. The researchers believe that the patient is not suitable to participate in the study.
1 Year
14 Years
ALL
No
Sponsors
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Nanjing Children's Hospital
OTHER
Children's Hospital of Fudan University
OTHER
Sinobioway Cell Therapy Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongjun Fang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Nanjing Children's Hospital
Kuiran Dong, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
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Nanjing Children's Hospital
Nanjing, Jiangsu, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Thomas S, Straathof K, Himoudi N, Anderson J, Pule M. An Optimized GD2-Targeting Retroviral Cassette for More Potent and Safer Cellular Therapy of Neuroblastoma and Other Cancers. PLoS One. 2016 Mar 31;11(3):e0152196. doi: 10.1371/journal.pone.0152196. eCollection 2016.
Related Links
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An Optimized GD2-Targeting Retroviral Cassette for More Potent and Safer Cellular Therapy of Neuroblastoma and Other Cancers
Other Identifiers
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WM-CART-07
Identifier Type: -
Identifier Source: org_study_id
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