Advanced Solid Tumor
Conditions
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.
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.
Interventions
DRUGKT095 CAR-T injection
Clearance of lymphocytes
Sponsors
The First People's Hospital of Lianyungang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity | Up to 2 years | DLT |
| Maximum tolerable dose | Up to 2 years | MTD |
Countries
China
Contacts
Primary Contactxiaodong jiang, PhD
Outcome results
None listed