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This is a clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China.
This is a single-center, single-arm, open-label study. This study is planned to enroll about 30 subjects with advanced solid tumors. Autologous CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KT095 CAR-T | Experimental | KT095 CAR-T injection Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KT095 CAR-T injection | Drug | Clearance of lymphocytes |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | DLT | Up to 2 years |
| Maximum tolerable dose | MTD | Up to 2 years |
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Inclusion Criteria:
Aged 18-70 and of both sexes;
Advanced solid tumor diagnosed by histology or pathology;
Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
The ECOG score is 0-2, and the expected survival time is more than 12 weeks;
Laboratory test results should at least meet the following requirements:
Left ventricular ejection fraction ≥40%; Creatinine ≤200 umol/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L; Hemoglobin ≥80g/L; Oxygen saturation of blood 91%; Total bilirubin ≤2×ULN; ALT and AST 2.5 x ULN or less; The criteria for abnormal ALT and AST due to disease (e.g., liver metastases or bile duct obstruction) or Gilbert syndrome can be relaxed to ≤5×ULN.
Having venous access for blood collection or single blood collection;
The patient voluntarily participated and signed the informed consent in person.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaodong jiang, PhD | Contact | 0518-85767557 | irb_lygyyy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lianyungang First People's Hospital | Lianyungang | Jiangsu | 222000 | China |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |