Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000016683
• Date of registration: 05/03/2015
• Prospective Registration: Yes
• Primary sponsor: Japan Agency for Medical Research and Development
• Public title: Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study.
• Scientific title: Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study. - Phase Ia/Ib study of Tax-targeting DC vaccine combined with anti-CCR4 Ab for ATL
• Date of first enrolment: 2015/03/13
• Target sample size: 9
• Recruitment status: Complete: follow-up continuing
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019348
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase I

Countries of recruitment

Japan

Contacts

• Name: Youko Suehiro
• Affiliation: National Hospital Organization Kyushu Cancer Center Cell Therapy/Hematology

• Name: Youko Suehiro
• Affiliation: National Hospital Organization Kyushu Cancer Center Cell Therapy/Hematology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases, sever allergy and severe infectious disease. 2) Patients who should receive systemic administration of steroid or immunosuppressive agents. 3) Non-hematological adverse event Grade 3 or more due to KW-0761 before the trial are not recover 4) After allogeneic hematopoietic stem cell transplantation, or allograft is planned 5) Presence of active central nerve lesion 6) Pregnant, lactating, or possibly pregnant women, or willing to be pregnant Severe psychiatric disorder 7) Complication with psychosis or psychotic symptoms 8) History of HAM/TSP 9) Active multiple cancers 10) Inappropriate for study entry judged by an attending physician

Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Adult T-cell leukemia/lymphoma

Intervention(s)

Tax-targeting DC vaccine KW-0761 (Mogamulizumab)

Primary Outcome(s)

Safety and tolerability of Tax-targeting DC vaccine combined with anti-CCR4 antibody

Secondary Outcome(s)

1) anti-ATL effect 2) progression- free survival 3) time to new treatment (TTNT) 4) tumor marker (sIL-2R) 5) HTLV-1 proviral load 6) CD4+CD25+Foxp3+ cells 7) level of Mogamulizumab 8) anti-ATL effect and adverse event in the follow up period

Source(s) of Monetary Support

Japan Agency for Medical Research and Development

Secondary Sponsor(s)

National Hospital Organization Kyushu Cancer Center

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 06/06/2018