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Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer - Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000722
Enrollment
14
Registered
2007-06-30
Start date
2005-07-01
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

Head and neck squamous cell carcinoma

Interventions

In the patients with distant metastasis, intra-venous and sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed at 1, 2, 7 and 8 weeks after the entry. In the patients with loca

Sponsors

Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Head and neck squamous cell carcinoma patients who have measurable lesion Patients whose life-expectancy is more than 6 months Performance status 0-1 Normal bone marrow, liver and renal functions NKT cells are detected at least 10 cells in 1 mL of peripheral blood and expanded more than 100 times in vitro.

Exclusion criteria

Exclusion criteria: Patients who have: been treated with previous therapy of at least 4 weeks; uncontrolled diabetes mellitus, interstitial pneumonia, pleural effusion, ascites and/or pericardial effusion; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; other cancers; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator.

Design outcomes

Primary

MeasureTime frame
Immunological response

Secondary

MeasureTime frame
Safety, Clinical response

Countries

Japan

Outcome results

None listed

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