UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020246
Receipt number R000023374
Scientific Title Safety evaluation of the preemptive immune-cell therapy against cancer
Date of disclosure of the study information 2015/12/21
Last modified on 2020/03/19 18:26:34

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Basic information

Public title

Safety evaluation of the preemptive immune-cell therapy against cancer

Acronym

Safety evaluation of the preemptive immune-cell therapy against cancer

Scientific Title

Safety evaluation of the preemptive immune-cell therapy against cancer

Scientific Title:Acronym

Safety evaluation of the preemptive immune-cell therapy against cancer

Region

Japan


Condition

Condition

Malignant tumor

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the safety, immunological response, and subject satisfaction of the preemptive immune-cell therapy against cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The defined safety*, immunological response**, and subject satisfaction*** 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

** : immunological status measured by flow cytometry and blood test

*** : subject satisfaction of the preemptive immune-cell therapy against cancer

Key secondary outcomes



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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Alpha beta T cell therapy
Gamma delta T cell therapy
NK (Natural Killer) 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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

A subject MUST:
1) Have risk factors for cancer and desire for receiving the preemptive immune-cell therapy.
2) Be > 40 of age when obtaining the informed consent.
3) Provide written informed consent.
4) Be determined to be appropriate by the doctor in charge.

Key exclusion criteria

A subject MUST NOT:
1) Be diagnosed with cancer.
2) Desire to receive the immune-cell therapy for the treatment of any allergic disease.
3) Be HIV or HTLV-1 positive
4) Be an allotransplant recipient.
5) Have a history or sign of interstitial pneumonia.
6) Have an active autoimmune disease.
7) Be a female who is pregnant, nursing, or of childbearing potential.
8) Be determined to be inappropriate by the doctor in charge.


A subject 70 years of age and above must be carefully considered for the risk of an autoimmune disease to enroll in this study.

Target sample size

100


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

Co-sponsor

01.Seta Clinic Tokyo
02.TouTou
03.Kitaosaka Medical Clinic
04.Fukuoka Medical Clinic
05.LSI Sapporo Clinic
06.TKC Tokyo clinic

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

NO

Study ID_1

jRCTc030190259 - jRCTc030190261

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.よろず医療相談蕩蕩(東京都)
03.北大阪メディカルクリニック(大阪府)
04.福岡メディカルクリニック(福岡県)
05.LSI札幌クリニック(北海道)
06.TKC東京クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 21 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 11 Month 01 Day

Date of IRB

2015 Year 12 Month 10 Day

Anticipated trial start date

2015 Year 12 Month 21 Day

Last follow-up date

2025 Year 12 Month 21 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 12 Month 17 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=R000023374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name