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

Early Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: KT095 CAR-T injection

• Registration Number: NCT05515185
• Lead Sponsor: The First People's Hospital of Lianyungang

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25
• Study Start: 2022-09-09
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KT095 CAR-T	KT095 CAR-T injection	KT095 CAR-T injection Intravenous infusion

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	Up to 2 years	DLT
Maximum tolerable dose	Up to 2 years	MTD

Trial Locations

Locations (1)

Lianyungang First People's Hospital; 🇨🇳 Lianyungang, Jiangsu, China