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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05515185
• Other study ID #: KT095
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 9, 2022
• Est. completion date: September 8, 2024

Study information

• Verified date: August 2022
• Source: The First People's Hospital of Lianyungang
• Contact: xiaodong jiang, PhD
• Phone: 0518-85767557
• Email: irb_lygyyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 8, 2024
• Est. primary completion date: September 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• KT095 CAR-T injection
Clearance of lymphocytes

Locations

Country	Name	City	State
China	Lianyungang First People's Hospital	Lianyungang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Lianyungang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity	DLT	Up to 2 years
Primary	Maximum tolerable dose	MTD	Up to 2 years