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

NCT ID: NCT05515185

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2024-09-08

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KT095 CAR-T

KT095 CAR-T injection Intravenous infusion

Group Type: EXPERIMENTAL

KT095 CAR-T injection

Intervention Type: DRUG

Clearance of lymphocytes

Interventions

KT095 CAR-T injection

Clearance of lymphocytes

Intervention Type: DRUG

Other Intervention Names

Fludarabine; Cyclophosphamide

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Lianyungang

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lianyungang First People's Hospital

Lianyungang, Jiangsu, China

Countries

China

Central Contacts

xiaodong jiang, PhD

Role: CONTACT

irb_lygyyy@163.com

0518-85767557

Facility Contacts

yi zhu, PhD

Role: primary

zhuyi@cart-med.com

13871188115

Other Identifiers

KT095

Identifier Type: -

Identifier Source: org_study_id