A clinical study of alpha-Galactosylceramide pulsed dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer. A phase II study.

A clinical study of alpha-Galactosylceramide pulsed dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer. A phase II study. - alpha-Galactosylceramide pulsed DCs in patients with NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007321

Enrollment

Registered

2012-02-17

Start date

2012-02-01

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

unresectable or recurrent non-small cell lung cancer

Interventions

Alpha-Galactosylceramide-pulsed dendritic cells are injected twice in one course.Two courses are scheduled.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients matching the following criteria. A histologically diagnosed advanced or recurrent non-small cell lung cancer and have already received firstline chemotherapy. At least one measurable lesion according to the RECIST ver1.1 criteria. Performance status (ECOG) 0-1. At least a four week interval between prior treatment. No hepatic, renal or bone marrow insufficiency. Survival expectation of more than three months. NKT cells are detected at least 10 cells/ml in peripheral blood. Written consent by the patient.

Exclusion criteria

Exclusion criteria: Patients matching any of the following criteria. Patients who have serious complications such as severe infection or malnutrition. Patients with pleural effusion or ascites, pericardial effusion, uncontrolled brain metastasis, simultaneous double cancer, receiving corticosteroid treatment, autoimmune disease, a past history of hepatitis, positive for HBs antigen, anti-HCV antibody, anti-HIV antibody, anti-HTLV-1 antibody, severe cardiac disease(NYHA classIII or more) or respiratory disease(Hugh-Jones classIII or more). Patients with a past history of hypersensitivity to albumin. Pregnant or breast feeding women. Patients whose medical condition cannot allow leukoapheresis. Patients who are considered ineligible to participate in the clinical trial.

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression free survival, response rate, disease control rate, safety, NKT cell-specific immune response	—

Countries

Japan

Contacts

Public ContactShinichiro Motohashi

Graduate School of Medicine, Chiba University Department of Medical Immunology

motohashi@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

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