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| Name | Class |
|---|---|
| Soochow T-Maximun Biotechnology Co. LTD | UNKNOWN |
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The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted IL-13 Rα2 UCAR-T cell injection | Biological | local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The proportion of patients whose tumor size decreases to the expected value and can continue to meet the expected minimum time limit。 | Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The time from enrolling into the trial to the first occurrence of disease progression or death from any cause。 | Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Lan, Doctor | Contact | +86-512-67784087 | szlq006@163.com | |
| Qing Zhu, Doctor | Contact | +86-512-67784086 | suzhouneurosurgeon@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215004 | China |
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| Targeted B7-H3 UCAR-T cell injection | Biological | local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time. |
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