Clinical Safety and Preliminary Efficacy of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors
This trial is active, not recruiting.
|Condition||malignant solid tumors|
|Treatment||mage-a4 tcr gene-modified t cells|
|Sponsor||Tianjin Medical University Cancer Institute and Hospital|
|Start date||July 2012|
|End date||November 2016|
|Trial size||15 participants|
|Trial identifier||NCT01694472, CIH-RXB-201205002|
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients, such as malignant melanoma and lung cancer.
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Objective response rate
time frame: Up to 12 months
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Sex: male or female - Age: from 18 to 80 years - Patients must have histologically confirmed solid tumors that have failed standard therapies (surgery, chemotherapy, radiotherapy) and for which no curative options exist, including, but not limited to: Non-Small Cell Lung Carcinoma Malignant melanoma Esophageal carcinoma Head and neck carcinoma - HLA-A*24:02 - MAGE-A4 positive in the test by RT-PCR on tumor tissue or immunohistochemistry of resected tissue of the patient. - PS ECOG 0 or <2 - Laboratory tests results 7 days before the start of treatment: White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25 × ULN - Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment - Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study - Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent Exclusion Criteria: - Patients with life-threatening condition or complication other than their basic disease - Pregnant or lactation. Patients both males and female with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration - Active systemic infections - History of neoplasms: other neoplasms - Medical history: active CNS disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy - Metastasis: clinical symptoms of brain metastasis - Other clinical trial: the subject received other clinical trial before this study - Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive - Compliance: poor compliance
|Official title||Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors|
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