UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000019030
Receipt number	R000022001
Scientific Title	Multicenter clinical study of immune-cell therapy in patients with malignant tumors.
Date of disclosure of the study information	2015/09/27
Last modified on	2020/03/19 18:26:04

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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

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

Obstetrics 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

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 or person

Institute

KOUSHIKAI,Non-profitmedicalcorporation

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

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

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022001

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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
Obstetrics and Gynecology	Pediatrics	Dermatology
Oto-rhino-laryngology	Urology	Radiology
Oral surgery	Neurosurgery