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

The First People's Hospital of Lianyungang

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: KT095 CAR-T injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05515185

KT095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-70 and of both sexes;

2. Advanced solid tumor diagnosed by histology or pathology;

3. Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;

4. B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.

5. Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;

6. The ECOG score is 0-2, and the expected survival time is more than 12 weeks;

7. 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.

8. Having venous access for blood collection or single blood collection;

9. The patient voluntarily participated and signed the informed consent in person.

Exclusion criteria

1. pregnant or lactating women;
2. Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
3. Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
4. Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
5. Those who have used any gene or cell therapy products;
6. History of epilepsy or other central nervous system diseases;
7. 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;
8. Other tumors in the past 5 years;
9. Patients with severe chest and ascites;
10. There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment;
11. Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation;
12. The investigator assessed that the patient was unable or unwilling to comply with the protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

KT095 CAR-T

Experimental group

Description:

KT095 CAR-T injection Intravenous infusion

Treatment:

Drug: KT095 CAR-T injection