Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene for therapy-resistant esophageal cancer

UMIN ID: UMIN000002395

Registered date:28/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Therapy-resistant esophageal cancer
• Date of first enrollment: 2009/08/01
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

First cohort; three patinets 1.TCR-gene-transduced autologous lymphocytes infusion 2x10*8 cells, single dose, IV 2. MAGE-A4 peptide administration 300 micrograms, mixed with Montanide(incomplete Freund's adjuvant), SQ, on day 14 and 28 after lymphocytes infusion
Second cohort; three patinets 1.TCR-gene-transduced autologous lymphocytes infusion 1x10*9 cells, single dose, IV 2. MAGE-A4 peptide administration 300 micrograms, mixed with Montanide(incomplete Freund's adjuvant), SQ, on day 14 and 28 after lymphocytes infusion
Third cohort; three patinets 1.TCR-gene-transduced autologous lymphocytes infusion 5x10*9 cells, single dose, IV 2. MAGE-A4 peptide administration 300 micrograms, mixed with Montanide(incomplete Freund's adjuvant), SQ, on day 14 and 28 after lymphocytes infusion

Outcome(s)

• Primary Outcome: # Safety; adverse events, including laboratory data and replication competent retrovirus(RCR)/linear amplification mediated-PCR(LAM-PCR)
• Secondary Outcome: # Kinetics and tumor infiltration of TCR/gene-transduced lymphocytes # Tumor-specific immune responses # Tumor shrinkage

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.Having following serious complications # Uncontrolled anigina pectoris, myocardial infarction, or heart failure # Uncontrolled diabetes mellitus or hytertention # Uncontrolled infection # X-ray-proven interstitial pneumonia or pulmonary fibrosis # Autoimmune disease # Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL Thrombosis tendency 2.History of serious hypersensitivity 3.Positive for HBs Ag, HCV Ab, HIV Ab, or HTLV-I Ab 4. Unctrolled pleural effusion, ascites, or pericardial effusion 5.Uncontrolled CNS metastasis 6.Systemic corticostoroid or immuno-suppressive therapy 7. Inappropriate for MAGE-A4 143-151 peptide administration, i.e. allergic to the peptide or adjuvant 8.Mental illness or drug dependency affecting informed consent 9.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm 10. Lasting less than four weeks from the previous enrollment to clinical trials 11.Inappropriate for study entry judged by an attending physician.

Related Information

• Primary Sponsor: Mie University Hospital
• Secondary Sponsor: Takara Bio Incorporation
• Source(s) of Monetary Support: Mie University