UMIN-CTR Clinical Trial

Basic information
Public title	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.
Acronym	alpha-Galactosylceramide pulsed DCs in patients with NSCLC
Scientific Title	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.
Scientific Title:Acronym	alpha-Galactosylceramide pulsed DCs in patients with NSCLC
Region	Japan

Condition
Condition	unresectable or recurrent non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy, safety and immunological response mediated by intravenous administration of alpha-Galactosylceramide pulsed Dendritic cells (Chiba-NKT) in patients with advanced or recurrent non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	overall survival
Key secondary outcomes	progression free survival, response rate, disease control rate, safety, NKT cell-specific immune response

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Alpha-Galactosylceramide-pulsed dendritic cells are injected twice in one course.Two courses are scheduled.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Motohashi
Organization	Graduate school of Medicine, Chiba University
Division name	Department of Medical Immunology
Zip code	2608670
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171
Email	motohashi@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Motohashi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Immunology
Zip code	2608670
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	motohashi@faculty.chiba-u.jp

Sponsor
Institute	Department of General Thoracic Surgery, Graduate school of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of the Graduate School of Medicine, Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel	043-222-7171
Email	motohashi@faculty.chiba-u.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 24 Day
Date of IRB	2011 Year 01 Month 24 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2017 Year 08 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 02 Month 17 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008631