Clinical trial · Interventional
Study Evaluating the Efficacy and Safety With CAR-T for Relapsed or Refractory Neuroblastoma in Children
Single Arm and Multicenter Clinical Trial to Evaluating the Efficacy and Safety of the Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) for Relapsed or Refractory Neuroblastoma in Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-arm, multicenter clinical study will treat the patient who have relapsed or refractory neuroblastoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the GD2 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GD2-targeted CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- 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
- interventionNames
- Biological: GD2-targeted CAR-T cells
Primary outcomes (1)
- measure
- The overall efficiency of patients with neuroblastoma after autologous CAR-T cell therapy
- timeFrame
- 28d,56d,90d
- description
- The overall efficiency will be determined by the evaluation of CT/MRI scans and bone marrow biopsy. Assessment of tumor remission rate according to International Neuroblastoma Response Criteria. The overall efficiency = (complete remission (CR) number + the number of very good partial remission (VGPR) number + partial response (PR) number + mixed reaction (MR) number + no response (NR) number) / total number of cases receiving treatment.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Up to diagnostic criteria for relapsed or refractory neuroblastoma or high-risk patients,including: * 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: 1. Positive pregnancy tests. 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.
References
Publications (1)
- BACKGROUNDThomas 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. PMID 27030986