Actively Recruiting
Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
11
Participants Needed
1
Research Sites
791 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single arm, open-label, intravenous infusion of Anti- Epidermal growth factor receptor (EGFR) Chimeric Antigen Receptor (CAR) T cells modified by C-X-C Chemokine receptor type 5 (CXCR 5) in patients with advanced adult non-small cell lung cancer (NSCLC).
CONDITIONS
Official Title
Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any screening procedures
- Age between 18 and 75 years
- Histologically or cytologically confirmed advanced non-small cell lung cancer
- Positive EGFR expression in tumor with a score of 2+ or more by immunohistochemical test
- CXCL13 positive rate of 10% or higher in pathology
- At least one measurable tumor lesion according to RECIST 1.1
- Expected survival time of at least 12 weeks
- Eastern Oncology Group performance status score of 0 or 1
- Adequate liver and kidney function (serum creatinine ≤1.6 mg/ml or creatinine clearance ≥40 ml/min/1.73m; total bilirubin <1.5 times upper limit of normal)
- Stable hemodynamics with left ventricular ejection fraction ≥50%
- Sufficient bone marrow reserves (white blood cells ≥2 x 10^9/L; platelets ≥100 x 10^9/L; hemoglobin ≥100 g/L)
- Discontinued therapeutic dose glucocorticoids at least 2 weeks before infusion; allowed physiological replacement doses
- Discontinued immunosuppressive drugs at least 4 weeks before selection
- Discontinued granulocyte colony factor at least 1 week before plasmapheresis
- Use of effective contraception for women of childbearing age and all male subjects for at least 52 weeks after infusion until two consecutive PCR tests confirm absence of CAR-T cells
You will not qualify if you...
- Previous treatment with any gene therapy product including CAR-T
- Uncontrolled hypertension (>160/95) or unstable coronary artery disease
- Decompensated congestive heart failure (above New York Heart Association Class II) or recent myocardial infarction within 6 months
- Severe liver or kidney dysfunction or consciousness disorders
- Antitumor chemotherapy other than lymphocyte clearance chemotherapy within 14 days before infusion
- Use of other investigational drugs within 30 days before infusion
- Radiotherapy or TKI treatment within 2 weeks before infusion
- Active hepatitis B with HBV DNA >1000 cps/ml
- Positive for HIV antibody, hepatitis C antibody, or syphilis spirochete
- Positive sputum smear or tuberculosis infection T cell test
- Interstitial lung disease or pneumonia
- Uncontrolled acute life-threatening infections
- Untreated or unstable central nervous system metastasis or large pericardial effusion
- Previous or concurrent second tumor except adequately treated basal/squamous cell carcinoma, in situ cervical or breast cancer with no recurrence for at least 3 years, or fully removed tumors with remission for 5 years
- Pregnant or breastfeeding women
- History or presence of T cell tumors
- Autoimmune or inflammatory neurological disorders such as Guillain-Barre syndrome or amyotrophic lateral sclerosis
- Other conditions deemed by investigators to interfere with study compliance or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510260
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD, PhD
CONTACT
B
Bingjia He, 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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