B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open, Single-arm Clinical Study of Autologous T Cells (CAR-T) Targeting B7-H3 Chimeric Antigen Receptor Gene in the Treatment of Patients With Advanced Gastrointestinal Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: KT095 CAR-T injection


Participation Criteria
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Eligibility Criteria
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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: pregnant or lactating women; Chemotherapy or radiotherapy was used within 3 days before the blood collection period; Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids); Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period; Those who have used any gene or cell therapy products; History of epilepsy or other central nervous system diseases; 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; Other tumors in the past 5 years; Patients with severe chest and ascites; There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment; Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation; The investigator assessed that the patient was unable or unwilling to comply with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KT095 CAR-T<br>KT095 CAR-T injection Intravenous infusion | Drug: KT095 CAR-T injection<br>* Clearance of lymphocytes<br>* Other names: Cyclophosphamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity | DLT | Up to 2 years | 
| Maximum tolerable dose | MTD | Up to 2 years |