B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KT095 CAR-T KT095 CAR-T injection Intravenous infusion |
Drug: KT095 CAR-T injection
Clearance of lymphocytes
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicity [Up to 2 years]
DLT
- Maximum tolerable dose [Up to 2 years]
MTD
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18-70 and of both sexes;
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Advanced solid tumor diagnosed by histology or pathology;
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Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
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B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
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Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
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The ECOG score is 0-2, and the expected survival time is more than 12 weeks;
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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.
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Having venous access for blood collection or single blood collection;
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The patient voluntarily participated and signed the informed consent in person.
Exclusion Criteria:
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pregnant or lactating women;
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Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
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Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
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Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
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Those who have used any gene or cell therapy products;
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History of epilepsy or other central nervous system diseases;
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Active hepatitis B or C virus, defined as: hepatitis B surface antigen HBsAg or hepatitis B core antibody HBcAb positive subjects with peripheral blood HBV DNA titer above the detection limit; HCV antibody positive for hepatitis C and HCV RNA positive in peripheral blood; People infected with HIV and syphilis;
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Other tumors in the past 5 years;
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Patients with severe chest and ascites;
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There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment;
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Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation;
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The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lianyungang First People's Hospital | Lianyungang | Jiangsu | China | 222000 |
Sponsors and Collaborators
- The First People's Hospital of Lianyungang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KT095