Clinical Safety and Preliminary Efficacy of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01694472
First received: September 23, 2012
Last updated: November 26, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Malignant Solid Tumors
Biological: MAGE-A4 TCR Gene-Modified T Cells
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    CR + PR = ORR


Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAGE-A4 TCR Gene-Modified T Cells Biological: MAGE-A4 TCR Gene-Modified T Cells
The study consists of a 2-dose escalation scheme, and the patient receives twice in each dose. The starting dose is 1-3 x 10^9 cells of each TCR gene-modified cells and the second one is 3-8 x 10^9 cells of each TCR gene-modified cells. Two weeks after the first infusion the patient receives the same dose again, followed by infusions of IL-2 for 5 days. Thereafter, the patient receives peptide vaccinations on days 21 and 28.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694472

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01694472     History of Changes
Other Study ID Numbers: CIH-RXB-201205002
Study First Received: September 23, 2012
Last Updated: November 26, 2013
Health Authority: China: Institutional Review Board of Tianjin Cancer Hospital

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014