Phase 2 Study of Anti-CCR4 MBA KW-0761 in subjects with PTCL

• Research type

  Research Study

• Full title

  Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) in Subjects with Previously Treated Peripheral T-cell Lymphoma (PTCL)

• IRAS ID

  93666

• Contact name

  John Radford

• Sponsor organisation

  Kyowa Hakko Kirin Pharma, Inc.

• Eudract number

  2011-004151-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The 0761-007 Study is an Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) in Subjects with Previously Treated Peripheral T-Cell Lymphoma (PTCL). PTCL is a rare disease that is difficult to diagnose and treat. The majority of PTCL patients are over 60 years old and present with advanced disease. Some PTCL subtypes respond well to combined chemotherapy but in most cases disease become resistant to chemotherapy and disease recurs. Overall survival of PTCL patients is poor and therefore new and more effective therapies are required. KW-0761 targets CCR4. CCR4 is found on the T-Cell surface and suppresses the patient??s antitumour immune response which allows the T cell to transform into a malignant cell. As KW-0761 binds to CCR4 it stops CCR4 from suppressing the antitumour immune response, thus stopping the T-cell transforming into a malignant cell. KW-0761 has been shown to be safe and tolerable in several clinical trials and represents a promising treatment for patients with previously treated PTCL. Approximately 35 subjects male or female who are least 18 years of age with confirmed PTCL who have either become resistant to chemotherapy or their disease has recurred will enrol into the study. Treatment will be given intravenously over 1 hour on Days 1, 8, 15 and 22 of the first cycle and Days 1 and 15 for subsequent cycles. Patients who experience a complete response (CR) may be treated for up to 2 additional cycles. After that, they may continue to receive a monthly treatment of KW-0761 at the discretion of their doctor. Patients who do not achieve CR may continue on treatment until progressive disease (PD) supervenes or unacceptable toxicity occurs. The treatment will be given in NHS Hospitals in an outpatient setting. The Study is expected to last for 36 months.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0315

• Date of REC Opinion

  16 Mar 2012

• REC opinion

  Favourable Opinion