Actively Recruiting
Genetically Modified T Cells Treating Malignant Tumors
Led by Yi Zhang · Updated on 2024-09-25
100
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors in First Affiliated Hospital of Zhengzhou University, China.
CONDITIONS
Official Title
Genetically Modified T Cells Treating Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have malignant tumors confirmed by histopathology or cytology, including but not limited to non-small cell lung cancer, esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, kidney cancer, cervical squamous cell carcinoma, ovarian cancer, breast cancer, melanoma, brain glioma, lymphoma
- Age between 18 and 75 years
- Adequate hematopoietic function: ANC >1500 cells/mm3, platelet count >50,000 cells/mm3, hemoglobin >9.0 g/dL, absolute lymphocyte count >9 cells/mm3
- Adequate liver and kidney function: AST and ALT ≤2.5 times upper limit of normal (ULN) without liver metastasis or ≤5 times ULN with liver metastasis; bilirubin ≤1.5 times ULN (excluding non-hepatic causes); creatinine ≤2.0 times ULN; creatinine clearance ≥40 mL/min
- Clotting parameters: PT/INR <1.5 ULN, PTT/αPTT <1.5 ULN
- Positive expression of at least one target antigen (Mesothelin, NKG2D, HER2, CD276, CD19, BCMA, or others) in tumor tissue
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Expected survival greater than 6 months
- Voluntary agreement to participate
You will not qualify if you...
- Received anti-PD1, anti-PD-L1, anti-PD-L2 antibody therapy or other immunotherapy within one month before this study
- History of organ transplantation
- Pregnant or breastfeeding
- Positive for high baseline HBV DNA levels (≥2000 IU/ml), HIV antibodies, hepatitis C antibodies, or treponema pallidum antibodies
- Active infection
- Active brain metastases (except asymptomatic or stable after treatment)
- Presence of a second tumor, except certain skin, bladder, cervical, or thyroid cancers with complete response over 5 years without treatment during the study
- Severe autoimmune diseases requiring long-term systemic immunosuppressive therapy
- Allergies
- NYHA heart failure grade ≥2, uncontrolled hypertension, recent myocarditis, or heart attack within one year
- Thrombotic diseases with active bleeding needing treatment
- Serious uncontrolled diseases or conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Y
Yi Zhang, MD
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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