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Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

Phase 1
18 Years
80 Years
Open (Enrolling)
Malignant Solid Tumors

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Trial Information

Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Objective response rate

Outcome Description:


Outcome Time Frame:

Up to 12 months

Safety Issue:



China: Institutional Review Board of Tianjin Cancer Hospital

Study ID:




Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

  • Malignant Solid Tumors
  • Neoplasms