NCT05515185Not yet recruitingEarly Phase 1
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
The First People's Hospital of Lianyungang1 site in 1 country30 target enrollmentStarted: September 9, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18-70 and of both sexes;
- •Advanced solid tumor diagnosed by histology or pathology;
- •Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
- •B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
- •Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
- •The ECOG score is 0-2, and the expected survival time is more than 12 weeks;
- •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.
- •Having venous access for blood collection or single blood collection;
- •The patient voluntarily participated and signed the informed consent in person.
Exclusion Criteria
- •pregnant or lactating women;
- •Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
- •Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
- •Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
- •Those who have used any gene or cell therapy products;
- •History of epilepsy or other central nervous system diseases;
- •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;
- •Other tumors in the past 5 years;
- •Patients with severe chest and ascites;
- •There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment;
- •Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation;
- •The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Arms & Interventions
KT095 CAR-T
Experimental
KT095 CAR-T injection Intravenous infusion
Intervention: KT095 CAR-T injection (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity
Time Frame: Up to 2 years
DLT
Maximum tolerable dose
Time Frame: Up to 2 years
MTD
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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