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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