UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015410 |
|---|---|
| Receipt number | R000017919 |
| Scientific Title | Clinical study of PepTivator(R) WT1-added autologous gamma/delta T cells therapy for cancer patients. |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2017/08/31 11:11:25 |
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Basic information
Public title
Clinical study of PepTivator(R) WT1-added autologous gamma/delta T cells therapy for cancer patients.
Acronym
Clinical study of PepTivator(R) WT1-added autologous gamma/delta T cells therapy for cancer patients.
Scientific Title
Clinical study of PepTivator(R) WT1-added autologous gamma/delta T cells therapy for cancer patients.
Scientific Title:Acronym
Clinical study of PepTivator(R) WT1-added autologous gamma/delta T cells therapy for cancer patients.
Region
| Japan |
Condition
Condition
Patients who have malignant tumor with WT1-positive.
Patients who have ever received DC vaccination with WT1 peptide, or WT1 antigen.
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 | Dermatology | Oto-rhino-laryngology |
| Urology | Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of PepTivator(R) WT1-pulsed autologous gamma/delta T cells.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Immunological responses
Efficacy
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
PepTivator(R) WT1-added Autologous gamma/delta T cells are injected on day0, day28.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with histologically confirmed malignant tumors.
2)Patients who recognized WT1 expression on tumor tissue.
Blood cancer patients who recognized WT1 expression in tumor cells.
3)Patients with a past history of a positive DTH.
4)Performance Status is 0-2.
5)No serious abnormality in bone marrow, liver, and renal functions.
6)Informed consent has been obtained .
Key exclusion criteria
Patients who have:
1)Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them
2)Serious drug allergy
3)Active autoimmune disease
4)Active enteritis
5)Positive for HIV or HTLV-1
6)Received continuous systemic steroids
7)Other cancers
8)Active infections
9)Serious cardiac disease
10)Pregnant or lactating
11)Any reason why, in the opinion of the investigator, the patient should not participate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
Seta Clinic Group
Division name
Center for Clinical Trials and Research
Zip code
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 102-0062 JAPAN
TEL
03-5244-5751
kamigaki@j-immunother.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ibe |
Organization
Seta Clinic Group
Division name
Center for Clinical Trials and Research
Zip code
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 102-0062 JAPAN
TEL
03-5244-5751
Homepage URL
scrc@j-immunother.com
Sponsor or person
Institute
Seta Clinic Group
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
瀬田クリニックグループ
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 10 | 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
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 10 | Day |
Last modified on
| 2017 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017919
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
