Autologous Dendritic Cell Vaccine Therapy Targeting HTLV-1 Specific Antigen for Adult T-Cell Leukemia/Lymphoma

Autologous Dendritic Cell Vaccine Therapy Targeting HTLV-1 Specific Antigen for Adult T-Cell Leukemia/Lymphoma A Phase II multicenter randomized controlled Study - Autologous DC Vaccine Therapy Targeting HTLV-1 Specific Antigen for ATLL A Phase II Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2073210013

Enrollment

Registered

2021-04-20

Start date

2021-04-20

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 Adult T-Cell Leukemia/Lymphoma

Interventions

Administered ATL-DC-101 subcutaneous of near the regional lymph node. ATL-DC-101 is administered 3 times with two-week interval at a dose of 5.0 x 10^6 cells.

D007279

subcutaneous injections

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Pre-treated ATL patient with following criterias 1) PR or better results with the pretreatment 2) ATL in acute type lymphoma type, or chronic type with unfaborable prognostic factors 3) Pre-treatment of chemo therapy and/or radio therapy 4) no nessecity of having target lesion (mesurable mass, ATL cells in peripheral blood, or skin lesion) (2) Positive for any of HLA-A*0201, *2402, *1101, or *0207 (3) 20 years old and over (4) No recurrence has been confirmed for at least four weeks after previous therapy (chemo therapy and/ or radio therapy) (5) ECOG performance status 0 or 1 (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) Writtenn consent for participation to this study

Exclusion criteria

Exclusion criteria: (1) Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases. (2) Patients who receive systemic administration of steroid or immunosuppressive agents. (3) Patients with severe active infectious disease (except for HTLV-1 infection) (4) Patiients with allogeneic transplantation have been carried out or scheduled. (5) Patients with severe allergy and/ or drug hypersensitivity. Patients with a history of shock due to benzylpenicillin. (6) Presence of active central nervous system lesion (7) Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant (8) Severe psychiatric disorder (9) History of HAM/TSP (10) Active multiple cancers (11) Inappropriate for study entry judged by an attending physician

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Safety and tolerability Effectiveness	—

Contacts

Public ContactYouko Suehiro

National Hospital Organization Kyushu Cancer Center

suehiro.y22@gmail.com+81-92-541-3231

Outcome results

None listed

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