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

JRCT ID: jRCT2073210013

Registered date:20/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult T-Cell Leukemia/Lymphoma
• Date of first enrollment: 20/04/2021
• Target sample size: 34
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Progression Free Survival

Secondary Outcome

Safety and tolerability
Effectiveness

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Suehiro Youko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development