Actively Recruiting
EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast Cancer
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
30
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open, exploratory clinical study to evaluate the safety and efficacy of EGFR/B7H3 CAR-T in patients with EGFR/ B7H3-positive advanced solid tumors (lung cancer and triple-negative breast cancer)
CONDITIONS
Official Title
EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any screening procedure
- Age between 18 and 75 years
- Histologically or cytologically confirmed advanced lung cancer or triple-negative breast cancer
- EGFR/B7H3 expression confirmed positive in tumor within 3 months before consent
- At least one measurable lesion per RECIST 1.1 within one month prior to screening
- Expected survival of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ function with ALT and AST less than 3 times normal, total bilirubin less than 1.5 times normal, and serum creatinine less than 1.5 times normal
- Stable hemodynamics with left ventricular ejection fraction (LVEF) of 50% or higher
- Sufficient bone marrow reserves (white blood cells ≥ 1 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 100 g/L)
- Women of childbearing age and all male subjects agree to use effective contraception for at least 52 weeks after CAR-T infusion until two consecutive PCR tests show no CAR-T cells
You will not qualify if you...
- Uncontrolled hypertension over 160/95 mmHg or unstable coronary artery disease
- Severe liver or kidney dysfunction or consciousness disorder
- Chemotherapy (other than lymphocyte clearance) within 14 days prior to CAR-T infusion
- Receipt of other study drugs within 14 days before infusion
- Radiotherapy or tyrosine kinase inhibitor (TKI) treatment within 2 weeks before infusion
- Active hepatitis B with HBV DNA over 1000 IU/mL
- Positive for HIV, hepatitis C, or syphilis antibodies
- Positive sputum smears or tuberculosis T cell test
- Interstitial lung disease or pneumonia
- Uncontrolled acute life-threatening infections within 72 hours prior to infusion
- Primary central nervous system tumor or metastasis, except stable or asymptomatic brain metastases treated over 4 weeks ago
- Large pericardial effusion with pericardial metastasis
- Prior or concurrent second tumors except adequately treated basal cell or squamous cell carcinoma, carcinoma in situ of cervical or breast cancer with no recurrence for at least 3 years, or primary malignancy in remission for 5 years
- Pregnant or lactating women
- History or presence of T-cell tumors
- Active neuroautoimmune or inflammatory disorders such as Guillain-Barre syndrome or amyotrophic lateral sclerosis
- Other conditions deemed unsuitable by the investigator for trial 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, Guangdong, China
Actively Recruiting
Research Team
Z
Zhang Zhenfeng, PhD
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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