Status:
TERMINATED
A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors
Lead Sponsor:
Shanghai East Hospital
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
Solid Tumors, Adult
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C...
Detailed Description
This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C...
Eligibility Criteria
Inclusion
- The subjects have been fully informed of the possible risks and benefits of participating in the study and have signed the informed consent form;
- Age 18-70 years;
- Immunohistochemistry of tumor tissue samples indicates Claudin18.2 positive ;
- Recurrent or metastatic advanced solid tumors (including advanced gastric cancers and non-gastric cancers) and have been failed to prior lines of systemic treatment
- According to the RECIST v1.1, at least one measuable tumor lesion;
- ECOG performance status score of 0-1;
- Expected survival ≥ 3 months;
- Subjects should have adequate organ functions before screening and treatment.
- Women of childbearing age must have a negative blood pregnancy test; subjects of childbearing potential must use effective contraception for ≥ 1 year after the final study treatment.
Exclusion
- Previous CAR-T cell therapy or other cell therapies or therapeutic tumor vaccination against any target;
- Any previous therapy targeting Claudin18.2;
- Prior antitumor therapy with insufficient washout period;
- Pregnant or lactating women;
- Brain metastases with central nervous system symptoms;
- Uncontrolled diabetes;
- Oxygen is required to maintain adequate blood oxygen saturation;
- Gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention;
- Clinically significant liver disorders (including liver cirrhosis, active viral hepatitis or other hepatitis);
- HIV, Treponema pallidum or HCV serologically positive;
- Severe underlying disease
- New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 50%; unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) in the past 6 months; history of severe non-ischemic cardiomyopathy; or severe uncontrolled arrhythmia;
- Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04467853
Start Date
September 21 2020
End Date
July 17 2023
Last Update
August 15 2023
Active Locations (3)
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1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Shanghai East Hospital
Shanghai, China/Shanghai, China, 200126
3
Shanghai Artemed Hospital
Shanghai, Shanghai Municipality, China