Phase I study of a therapeutic vaccine in ATL patients with autologous dendritic cells pulsed with Tax peptides

Phase I study of a therapeutic vaccine in ATL patients with autologous dendritic cells pulsed with Tax peptides - Phase I study of Tax specific DC vaccine for ATL patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011423

Enrollment

Registered

2013-08-08

Start date

2012-09-15

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

Autologous Tax peptide pulsed dendritic cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Pre-treated ATL patients in stable disease for at least one month (exclude 1st CR) 2)positive for any of HLA-A*0201, *2402, or *1101 3)No previous therapy has been performed within 4 weeks before vaccination 4)ECOG performance status 0 or 1 5) Meet the following criteria for apheresis Hb >= 8.0 g/dL platelet count >= 100,000/mm3, <= 600,000/mm3 systolic blood pressure >= 90 mmHg 6) Meet the following criteria for organ function serum-Cr < 2.0 mg/dL. AST, ALT < 3 X ULN value, 7)Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis 8)Positive for complete type of HTLV-1 Tax which consists of intact amino acids arrangement in the epitope region 9)Negative for HLA-A*0201/Tax 11-19, HLA-A*2402/Tax301-309,HLA-A*1101/ Tax88-96 tetramer CD8+T cells, or impaired function of Tax tetramer CD8+T cells 10)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) Presence of active brain metastases 4) Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant 5) Severe psychiatric disorder 6) History of HAM/TSP 7) Active multiple cancers 8) Inappropriate for study entry judged by an attending physician

Design outcomes

Primary

Measure	Time frame
Safety of administrating dose of Tax specific dendritic cells	—

Secondary

Measure	Time frame
1) Feasibility of DC preparation 2) Tax specific CTL response 3) Anti viral (HTLV-1) effect 4) Anti leukemia/lymphoma effect	—

Countries

Japan

Contacts

Public ContactYouko Suehiro

National Hospital Organization Kyushu Cancer Center Hematology

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

Outcome results

None listed

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