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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011555
Receipt No. R000013518
Scientific Title Phase I/IIa clinical study of the immunotherapy using ZNK cell for solid cancer
Date of disclosure of the study information 2013/08/22
Last modified on 2021/02/15

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Basic information
Public title Phase I/IIa clinical study of the immunotherapy using ZNK cell for solid cancer
Acronym Phase I/IIa clinical study of the immunotherapy using ZNK cell for solid cancer
Scientific Title Phase I/IIa clinical study of the immunotherapy using ZNK cell for solid cancer
Scientific Title:Acronym Phase I/IIa clinical study of the immunotherapy using ZNK cell for solid cancer
Region
Japan

Condition
Condition Solid cancer, Malignant tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to assess the safety and feasibility of the newly developed immunotherapy using ZNK cell for solid cancer patients.
The secondary objectives are to confirm the maximum tolerance dose of ZNK cells and to assess the anti-tumor immune response as an efficacy of this regimen on RECIST guideline.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events and safety
Maximum tolerated dose (MTD)
Ratio of NK cell in the blood after the ZNK cell dosage
Key secondary outcomes -Antitumor immune response (RECIST)
-Progress- free survival(PFS)
*four weeks after the last ZNK cell injection and every three months until progressive disease (PD) is diagnosed.
-Overall survival(OS)
*follow-up phase: for 2 years

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 ZNK cell is injected approximately every two weeks for a total six times per case. The dosage amount of ZNK cells are 10^6 cells on the first injection, 10^7 cells on the second and 10^8 cells on the third to sixth injections.
Injections of ZNK cell can be repeated unless patient's general condition is aggravated or adverse event, which cause incapability of continuing to administrate ZNK cell, is observed.
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 The subjects must satisfy the following conditions.
1) Patients must be histopathologically or cytologically diagnosed as solid cancer.
2) Patients must have target lesions for evaluating the efficacy by RECIST.
3) Patients must be at a score level of 0 or 1 of performance status (ECOG).
4) Patient's age must be between 20 to 75 years old.
5) Concerning the function of major organs (bone marrow, liver, kidney, and etc.), patients must satisfy the followings:
a) WBC >=3,000/mm3
b) Neutrophil >=1,500/mm3
c) Platelet >=80,000/mm3
d) Hemoglobin >=9.0g/dL
e) AST, ALT<=2.5 times of facility criterion
f) Total bilirubin<=2.5 times of facility criterion
g) Serum Creatinine <=1.5mg/dL
h) No serious abnormality on an electrocardiogram
6) Patients must be expected to survive more than four months from initial administration of ZNK cell.
7) Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients with hematological neoplasms including leukemia.
2) Patients with possibility of severe bleeding coursed by anti-tumor effects such as metastatic brain tumor or central type of lung cancer.
3) Patients with active synchronous malignancies.
4) Patients with history of a serious allergic reaction.
5) Patients with serious complications or coexisting illness such as myelosuppression, infectious disease, interstitial pneumonitis, pulmonary fibrosis, or poorly controlled cardiac, renal, liver and diabetes.
6) Patient with pleural or pericardial effusion with requiring treatment.
7) Woman who are pregnant or breastfeeding, or with the will of the pregnancy.
8) Man with the will to impregnate
9) Patients with carrier of HTLV-1, HIV, HBV, HCV, and syphilis spirochete.
10) Patients with severe mental disorder.
11) Patient with history of the autoimmune disease.
12) Patients who are taking immunosuppressant.
13) Patients who are judged to be inadequate to participate in this study by doctors responsible for this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Nagai
Organization Nagasaki University Hospital
Division name Transfusion and Cell Therapy Unit
Zip code
Address Sakamoto 1-7-1, Nagasaki, Japan
TEL 095-819-7493
Email agwkn@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Nagai
Organization Nagasaki University Hospital
Division name Transfusion and Cell Therapy Unit
Zip code
Address Sakamoto 1-7-1, Nagasaki, Japan
TEL 095-819-7493
Homepage URL
Email agwkn@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Tella Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 22 Day

Related information
URL releasing protocol https://ar.iiarjournals.org/content/40/10/5687.long
Publication of results Published

Result
URL related to results and publications https://ar.iiarjournals.org/content/40/10/5687.long
Number of participants that the trial has enrolled 9
Results A total of nine patients were enrolled in this study, with one recruited twice. Overall, neither grade 2 or higher toxicities (CTCAE v5.0) caused by cell administration, nor adverse events causing discontinuation of protocol treatment were found. The maximally tolerated dose was therefore considered to be at least 10^8 cells. The overall response rate was 40.0% in 10 net cases.
Results date posted
2021 Year 02 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The diagnoses of patients were as follows: Four patients with colonic cancer, two patients with adenocystic carcinoma, and one patient each with renal, pancreatic, and ovarian cancer.
Participant flow A total of 9 patients were enrolled in the current study in accordance to the inclusion criteria of this study.
Adverse events The most common any grade AEs were grade 1 fatigue (n=5, 50.0%) and anorexia (n=4, 40.0%). These AEs were considered to be mainly due to exacerbation of the underlying disease.In case 2, grade 1 fever was observed for a few days from several hours after administration, and symptomatic treatment was temporarily required but the symptoms resolved. In case 4, a grade 1 skin rash appeared locally 6 to 7 hours after the administration and was observed over several days, then disappeared spontaneously without the need for treatment. There were no cases with hematological AEs. Overall, no grade 2 or higher CTCAE v5.0 toxicities associated with ZNK cell administration were found, and none of the patients reported an AE that led to discontinuation of ZNK cell treatment.
Outcome measures These results demonstrate that autologous ZNK cells are safe and well-tolerated in patients with different types of advanced solid tumors.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 23 Day
Date of IRB
2013 Year 07 Month 21 Day
Anticipated trial start date
2013 Year 08 Month 22 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 22 Day
Last modified on
2021 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013518

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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