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

NCT ID: NCT05515185

Condition: Advanced Solid Tumor

Conditions: Official terms:
Cyclophosphamide
Fludarabine

Study type: Interventional

Study phase: Early Phase 1

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: KT095 CAR-T injection
Description: Clearance of lymphocytes
Arm group label: KT095 CAR-T

Other name: Fludarabine

Other name: Cyclophosphamide

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Lianyungang First People's Hospital

Address:
City: Lianyungang
Zip: 222000
Country: China

Contact:
Last name: yi zhu, PhD

Phone: 13871188115
Email: zhuyi@cart-med.com

Start date: September 9, 2022

Completion date: September 8, 2024

Lead sponsor:
Agency: The First People's Hospital of Lianyungang
Agency class: Other

Source: The First People's Hospital of Lianyungang

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05515185

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