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

• Status: Not yet recruiting
• Trial end date: 2024-09-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First People's Hospital of Lianyungang
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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.