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.

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016683

Enrollment

Registered

2015-03-05

Start date

2015-03-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult T-cell leukemia/lymphoma

Interventions

Tax-targeting DC vaccine KW-0761 (Mogamulizumab)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pre-treated ATL patients who obtain more than SD by previous treatment 2) positive for any of HLA-A*0201, *2402, or *1101 3) No previous therapy has been performed within 4 weeks before vaccination; without the exacerbation 4) ECOG performance status 0 or 1 5) Meet the following criteria for organ function serum-Cr < 2.0 mg/dL. AST, ALT < 3 X ULN value, 6) Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis 7) Written informed consent obtained

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of Tax-targeting DC vaccine combined with anti-CCR4 antibody	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYouko Suehiro

National Hospital Organization Kyushu Cancer Center Cell Therapy/Hematology

suehiro.y@nk-cc.go.jp092-541-3231

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026