A phase I study of combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and autologous lymphocyte activated by autologous tumor tissue for patients with head and neck squamous cell carcinoma.

A phase I study of combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and autologous lymphocyte activated by autologous tumor tissue for patients with head and neck squamous cell carcinoma. - A phase I study of combined immunotherapy using alpha-GalCer pulsed APCs and activated autologous lymphocyte for patients with HNSCC.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009431

Enrollment

Registered

2012-11-29

Start date

2012-11-29

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

An injection of 100 million of alpha-GalCer pulsed APCs into nasal submucosa on day 18 and an intravenous administration of 10 million of CTLs activated by autologous tumor on day 21. An injection of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Advanced or recurrent head and neck squamous cell calcinoma; Obtainable tumor tisse; Performance status is 0 - 2; Normal bone marrow, liver and renal functions; Written informed concent.

Exclusion criteria

Exclusion criteria: Past histry of hepatitis, a positive response for HBs antigen/HCT antibody/HIV antibody/HTL-V1 antibody, recieived concurrent corticosteroid therapy, pregnancy or lactation, antoimmune disease, infection, uncontrolled diabetes mellitus, pulmonary fibrosis, serious cardiac disease, double cancer, invasion into carotid artery, pleural effusion, brain metastasis, nutritional disorder, judgement of physician

Design outcomes

Primary

Measure	Time frame
Safety profile	—

Secondary

Measure	Time frame
Evaluation of peripheral NKT cell specific immune response Clinical respose Recurrence free survival	—

Countries

Japan

Outcome results

None listed

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