Clinical trial · Interventional
CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients
Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
NCT03252171CI-TRIAL-00045995withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Project terminated due to revision of local regulations
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CAR-T Cell Immunotherapy | — | UNRESOLVED | — |
| GD2 Positive Glioma | Glioma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cell immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: CAR-T cell immunotherapy
- description
- Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen by infusion.
- interventionNames
- Biological: CAR-T cell immunotherapy
- type
- NO_INTERVENTION
- label
- No Intervention
Primary outcomes (1)
- measure
- The effectiveness of CAR-T cell immunotherapy
- timeFrame
- 3 months
- description
- It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. The primary GD2 positive patients, the best are glioma patients. 2. The recurrent GD2 positive patients, the best are glioma patients. 3. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters: * Absolute neutrophil count greater than 1500/mm3. * Platelet count greater than 100,000/mm3. * Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter). * Total bilirubin \< 1.5 times upper limits of normal. * Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2). * Seronegative for HIV antibody. * Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. 4. Patients must be willing to practice birth control during and for four months following treatment. NOTE: women of child-bearing age must have evidence of negative pregnancy test. 5. Patients must be willing to sign an informed consent. Exclusion Criteria: 1. The patients with multiple kinds of cancers are excluded. 2. Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded. 3. Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air. 4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded. 5. Pregnant and/or lactating women will be excluded. 6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors. 7. Patients with any type of primary immunodeficiencies will be excluded from the study. 8. Patients requiring corticosteroids (other than inhaled) will be excluded. 9. Patients with history of T cell tumors will be excluded. 10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.