Clinical trial NCT01694472: Clinical Safety and Preliminary Efficacy of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors
Official title: Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignant Solid Tumors
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: