Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 … (NCT05472857) | Clinical Trial Compass
UnknownPhase 1
Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
China30 participantsStarted 2022-08-08
Plain-language summary
This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. The age is between 18 and 70 years old (including the boundary value), both male and female.
✓. Subjects with advanced CLDN 18.2 positive malignant solid tumors confirmed by histology or cytology in the past (including advanced gastric cancer or esophagogastric junction adenocarcinoma, advanced pancreatic cancer, and metastatic ovarian cancer without standard treatment).
✓. All subjects are required to provide tumor tissue specimens that can be used for CLDN 18.2 analysis, which must be tumor histopathological specimens within 24 months before signing the informed consent, or fresh biopsy specimens collected within 6 months before cell reinfusion ; CLDN 18.2 histological staining of biopsy tumor tissue specimens is positive (defined as staining intensity ≥ 1+, positive rate ≥ 10%), the recommended antibody for detection is: Anti-Claudin18.2 antibody.
✓. Estimated life expectancy≥12 weeks.
✓. At least 1 measurable lesion per RECIST version1.1;
✓. ECOG performance status score of 0-1.
✓. The subject has adequate organ and bone marrow function.
Exclusion criteria
✕. Fertility status: Female patients of childbearing age or male patients whose sexual partners are females of childbearing age are willing to take medically approved high-efficiency contraceptive measures such as intrauterine devices from the time of signing the informed consent to 6 months after the last cell infusion or condoms (women of childbearing age include premenopausal women and women within 24 months of postmenopause).
✕
What they're measuring
1
Incidence of Treatment Related adverse events (AEs)
0. Subjects must sign and date written informed consent.
✕1. Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up and other research requirements.
✕. Pregnant and lactating women.
✕. Known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive or HBsAb positive, and HBV-DNA positive); acute or chronic active hepatitis C (HCV antibody positive) , and HCV-RNA was positive). Syphilis antibody positive; EB virus DNA quantification \>500 copies (or according to the positive standard detected by each research center); cytomegalovirus (CMV) infection (IgM positive).
✕. Serious infection in active stage or poorly controlled clinically.
✕. There is currently a heart disease requiring treatment or hypertension that is poorly controlled by the investigator (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure \> 90 mmHg after standardized antihypertensive drug treatment).
✕. Within 6 months before cell reinfusion, any of the following cardiac clinical symptoms or diseases: left ventricular ejection fraction (LVEF) \< 50%; previous history of coronary heart disease, myocardial infarction, severe heart failure and severe arrhythmia.