A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors
Trial Parameters
Brief Summary
This is a single-center, open-label clinical study of anti-HER2-CAR-T cells for HER2+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include HER2+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-HER2-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Eligibility Criteria
Inclusion Criteria: 1. Patients should understand and sign informed consent forms and voluntarily participate in clinical studies; 2. Age≥ 18, \< 70 years old, gender is not limited; 3. Locally advanced and/or metastatic solid tumors; HER2-positive expression in tumor tissues (staining 3+, or staining 2+ with HER2 gene amplification should be further performed by ISH and other methods) ; 4. Histology-confirmed solid tumors (breast cancer,gastric cancer, colorectal cancer, pancreas cancer, etc.), conventional treatment is ineffective or Intolerability conventional treatment or lack of effective treatment; 5. According to RECIST v 1.1, at least one measurable lesion with a maximum lesion diameter not exceeding 6 cm; 6. Expected survival≥ 12 weeks; 7. ECOG score≤ 2 ; 8. Adequate hematological function ; have no performed blood transfusion or received cell growth factor within 7 days before screening hematological evaluation:Neutrophil ≥ 1.0×10\^9/L;Hemoglobin≥ 80g/L;Platelet ≥ 75×10\^9/L;