UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter clinical study of immune-cell therapy in patients with malignant tumors.
Acronym	Multicenter clinical study of immune-cell therapy in patients with malignant tumors.
Scientific Title	Multicenter clinical study of immune-cell therapy in patients with malignant tumors.
Scientific Title:Acronym	Multicenter clinical study of immune-cell therapy in patients with malignant tumors.
Region	Japan

Condition
Condition	Malignant tumor
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Pediatrics Dermatology Oto-rhino-laryngology Urology Radiology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to contribute to improvements in the reliability and transparency of immune-cell therapy conducted at Seta Clinic Group and its affiliated medical institutions. The acceptable data, obtained from the multicenter study and evaluated periodically (independent evaluation for safety and scientific validity) by the Certified Committee for Regenerative Medicine, reported to the Minister of the Health, Labour and Welfare based on the Act on the Safety of Regenerative Medicine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The defined safety* and efficacy** set is analyzed and evaluated annually according to the Act on the Safety of Regenerative Medicine. *severity, date, frequency, duration, incidence rate and attribution of adverse events **clinical and antitumor effect evaluation, disease-specific overall survival and others (progression-free survival, relapse-free survival, efficacy rate, disease control rate and tumor marker levels)
Key secondary outcomes	Immunological 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	Maneuver
Interventions/Control_1	Alpha beta T cell therapy CTL (Cyototoxic T Lymphocytes) therapy Gammma delta T cell therapy NK (Natural Killer) cell therapy Dendritic cell therapy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diagnostic imaging or Pathological diagnosis of malignant tumor. 2)Informed consent has been obtained.
Key exclusion criteria	1) HIV Ab positive. 2) T cell- or NK cell-originated leukemia and/or lymphoma.(LAK therapy) 3)Patients who have previously treated allogenic transplantation. 4) Responsible doctors judged the patient inappropriate for the clinical study.
Target sample size	1800

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name Goto
Organization	KOUSHIKAI,Non-profitmedicalcorporation
Division name	Seta Clinic Tokyo
Zip code	101-0062
Address	3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
TEL	03-5280-0086
Email	goto@j-immunother.com

Public contact
Name of contact person	1st name Eri Middle name Last name Oguma
Organization	KOUSHIKAI,Non-profitmedicalcorporation
Division name	Center for Clinical Trials and Research
Zip code	101-0062
Address	3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
TEL	03-5244-5751
Homepage URL
Email	citeg@j-immunother.com

Sponsor
Institute	KOUSHIKAI,Non-profitmedicalcorporation
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	01.Seta Clinic Tokyo 02.LSI Sapporo Clinic 03.Kyoaikai Hospital 04.Sano Hospital 05.Toyoaki Clinic 06.Miki Hospital 07.Tozai Clinic Sendai 08.Omachi Medical and Surgical Clinic 09.Benibana Medical Clinic 10.Kaneko Clinic 11.Kikkoman General Hospital 12.Clinic Kashiwanoha 13.TouTou 14.Shinbashi Ekimae Medical Clinic 15.Azabu Clinic 16.TKC Tokyo clinic 17.Kanamecho Hospital 18.Kanamecho Home Care Clinic 19.Kawaguchi Gastroenterology Clinic 20.HAYAMA HEART CENTER 21.Niitsu Medical Center Hospital 22.Akita Clinic 23.Kanazawa Advanced Medical Center 24.Otaki Higashi Clinic 25.Meditopia Numazu Internal Medicine Clinic 26.Suzukake Central Hospital 27.Masuko Memorial Hospital 28.Nagoya Central Hospital 29.Koseikai Hospital 30.Akaiwa Hospital 31.Uno Hospital 32.Mutsuna Clinic 33.Wakaba Hospital 34.Takeoka Clinic 35.Muromachi Hospital 36.Kitaosaka Medical Clinic 37.IGT Clinic 38.Terao Clinic 39.Ishimoto Coloproctology Clinic 40.Yamashita Clinic 41.Takahashi Medical Clinic 42.Umi-Kaze Clinic 43.Hojo Hospital 44.Fukuoka Medical Clinic 45.Subaru Clinic 46.Medical City Eastern Hospital 47.Tsuruta Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Seta Clinic Group Certified Committee for Regenerative Medicine
Address	3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
Tel	03-5244-5751
Email	ccrm@j-immunother.com

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTc030190249 - jRCTc030190258
Org. issuing International ID_1	jRCT (Japan Registry Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

01.瀬田クリニック東京 （東京都） 02.LSI札幌クリニック （北海道） 03.共愛会病院 （北海道） 04.佐野病院 （北海道） 05.とよあきクリニック （青森県） 06.美希病院 （岩手県） 07.東西クリニック仙台 （宮城県） 08.大町内科外科クリニック （秋田県） 09.べにばな内科クリニック （山形県） 10.金子医院 （茨城県） 11.キッコーマン総合病院（千葉県） 12.クリニック柏の葉 （千葉県） 13.よろず医療相談蕩蕩（東京都） 14.新橋駅前内科クリニック （東京都） 15.麻布医院 （東京都） 16.TKC東京クリニック（東京都） 17.要町病院 （東京都） 18.要町ホームケアクリニック （東京都） 19.かわぐち消化器内科（神奈川県） 20.葉山ハートセンター（神奈川県） 21.新津医療センター病院 （新潟県） 22.秋田内科放射線科クリニック （新潟県） 23.金沢先進医学センター （石川県） 24.大滝東クリニック （福井県） 25.メディトピア沼津内科クリニック （静岡県） 26.すずかけセントラル病院 （静岡県） 27.増子記念病院 （愛知県） 28.名古屋セントラル病院 （愛知県） 29.光生会病院 （愛知県） 30.赤岩病院 （愛知県） 31.宇野病院 （愛知県） 32.六名クリニック （愛知県） 33.若葉病院（三重県） 34.竹岡診療所 （滋賀県） 35.室町病院 （京都府） 36.北大阪メディカルクリニック（大阪府） 37.IGTクリニック （大阪府） 38.てらおクリニック（兵庫県） 39.石本胃腸肛門クリニック （和歌山県） 40.山下クリニック （岡山県） 41.高橋メディカルクリニック （広島県） 42.海風診療所 （山口県） 43.北条病院 （愛媛県） 44.福岡メディカルクリニック（福岡県） 45.すばる診療所 （長崎県） 46.メディカルシティ東部病院 （宮崎県） 47.鶴田病院 （宮崎県）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 27 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	Terminated
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2015 Year 08 Month 30 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a paid study. Transition to jRCT (Japan Registry Clinical Trials).

Management information
Registered date	2015 Year 09 Month 15 Day
Last modified on	2020 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022001