Actively Recruiting
Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
Led by Sichuan University · Updated on 2024-10-30
18
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. In this study, the PD-L1 inhibitory signal was transformed into an activation signal in the tumor microenvironment, and enhanced the killing activity and survival ability of CAR-T cells. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2-positive solid tumors, and all enrolled subjects will receive HER2/PD-L1 CAR T cells via intravenous or thoracic/peritoneal cavity infusion.
CONDITIONS
Official Title
Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-75 years; subjects over 75 may be enrolled based on health status; no upper age limit for chest/abdominal CAR-T infusion
- Estimated life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Diagnosed with ovarian, non-small cell lung, breast, gastric, head and neck, pancreatic, colorectal, transitional cell carcinoma, endometrial carcinoma, sarcoma, glioblastoma, cholangiocarcinoma, or other listed cancers with systemic or serosal cavity metastasis or intolerance to standard treatment
- HER2 expression over 20% in tumors or metastatic cells by immunohistochemistry or fluorescence in situ hybridization
- Adequate blood counts: neutrophils ≥1×10^9/L, platelets ≥75×10^9/L, lymphocytes ≥0.5×10^8/L, hemoglobin ≥8.0 g/dl
- Kidney and liver function within specified limits: creatinine clearance ≥60ml/min, ALT/AST ≤2.5 times normal, total bilirubin ≤1.5 times normal
- Cardiac ejection fraction ≥50% with no pericardial effusion
- No serious autoimmune, immune deficiency diseases or conditions requiring immunosuppressive therapy
- At least 3 weeks since last chemotherapy or targeted therapy
- Use of reliable contraception before, during, and up to 1 year after treatment
- Voluntary participation with informed consent signed
- Side effects of last anti-tumor treatment reduced to grade 1 or less except hair loss
You will not qualify if you...
- Allergy to cytokines
- Uncontrolled active infections
- Acute or chronic graft-versus-host disease (GVHD)
- Other uncontrolled malignant tumors
- Active hepatitis B or C, or HIV infection exceeding normal limits
- Serious cardiovascular or cerebrovascular diseases such as coronary heart disease, angina, myocardial infarction, arrhythmia, stroke, or brain hemorrhage
- Grade 2-3 or poorly controlled hypertension
- History of difficult-to-control mental illness
- Long-term use of immunosuppressive agents after organ transplantation (except recent or current inhaled corticosteroids)
- Medical or mental history, or lab abnormalities increasing risk of study participation or drug administration
- Unstable pulmonary embolism, deep vein thrombosis, or major thromboembolic events within 6 months
- Pregnant or breastfeeding women, or planning pregnancy during treatment or within 1 year after
- Inability or unwillingness to comply with study procedures or consent requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Q
Qizhi Ma, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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