UCSD Solid Tumor Trial → CRX100 in Patients With Advanced Solid Tumors

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UCSD Solid Tumor Trial → CRX100 in Patients With Advanced Solid Tumors

2023-03-26 12:03| 来源: 网络整理| 查看: 265

Open to people ages 18 years and up

Subjects must meet all of the following criteria to be enrolled in this study:

1. Age ≥18 years at the time of consent. 2. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures. 3. Subjects must have histologically-confirmed diagnosis of one of the following tumors: triple negative adenocarcinoma of the breast (human epidermal growth factor receptor 2- estrogen receptor- and progesterone receptor- negative [HER2-/ER-/PR-]), adenocarcinoma of the colon or rectum (CRC), hepatocellular carcinoma (HCC), osteosarcoma, epithelial ovarian cancer, or gastric cancer. Documentation of the diagnosis with the original pathology report, or a recent biopsy, is required. 4. Subjects must have relapsed disease or be refractory or intolerant to standard care, or refusing standard therapies. 5. Subjects must have iRECIST evaluable disease using computed tomography (CT) or magnetic resonance imaging (MRI) with IV contrast , with at least one measurable target lesion. 6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Subjects must have recovered from the effects of recent surgery, radiation therapy, or chemotherapy. 8. Subjects must be free of active infections requiring treatment doses of antibiotics, antifungals, or antiviral medications. 9. No cellular therapy to be administered for at least 12 weeks prior to apheresis. 10. Adequate hematologic function at the time of screening, defined as: absolute lymphocyte count (ALC) >500 cells/mm3, absolute neutrophil count (ANC) >750 cells/mm3, hemoglobin >8 g/dL, and platelet count >50,000 cells/mm3. Hemoglobin and platelet count thresholds must be achievable without transfusion of red blood cells or platelets. 11. Adequate organ function, defined as: 1. Renal function: serum creatinine 50 mL/min 2. Adequate hepatic function: total bilirubin ≤1.5x institutional upper limit of normal; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional upper limit of normal, unless liver metastases are present, in which case it must be ≤5x ULN; International Normalized Ratio (INR) ≤1.5. For subjects with HCC, adequate hepatic function is defined as: total bilirubin ≤3x institutional upper limit of normal, AST/ALT ≤5x institutional upper limit of normal, INR ≤1.7, Child-Turcotte-Pugh score



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