UMIN-CTR Clinical Trial

Public title

A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors

Acronym

RNF43 peptide pulse DC with specifically activated lymphocytes therapy

Scientific Title

A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors

Scientific Title:Acronym

RNF43 peptide pulse DC with specifically activated lymphocytes therapy

Region

Japan

Condition

advanced solid tumors which already have finished available standard therapies.

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Pneumology	Hematology and clinical oncology	Surgery in general
Gastrointestinal surgery	Hepato-biliary-pancreatic surgery	Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate saftey and efficacy of RNF43 peptide pulse DC with specifically activated lymphocytes therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

safety

Key secondary outcomes

clinical efficacy and immunologic monitoring

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

First cohort; five patinets
1.RNF43 peptide specifically activated autologous lymphocytes infusion
5x10^7 cells, single dose, i.v.
2.RNF43 peptide pulse DC administration
on day 1,8 and 15

Interventions/Control_2

Second cohort; five patinets
1.RNF43 peptide specifically activated autologous lymphocytes infusion
2x10^8 cells, single dose, i.v.
2.RNF43 peptide pulse DC administration
on day 1,8 and 15

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Advanced solid tumors which already have finished available standard therapies.
2. Performance status 0-1 (ECOG).
3.HLA-A2402 or A0201-positive status.
4. PCR-confirmed RNF43-antigen expression of tumor cells
5.Having measurable tumor for assessing clinical responses
6.Patients who have recovered from the toxicity of any previous therapy for at least 4 weeks before trial entry.
7.Life expectancy of at least 3 months.
8.Adequate hematological function
WBC count more than 3000 /uL,
platelet count more than 100000/uL,
AST, ALT less than 3 X ULN value,
T-Bil less than 2.0mg/dl,
s-Cr less than 1.5mg/dl.
9.Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis.
10.Written informed consent obtained at the time of enrolment.

Key exclusion criteria

1.Patients with severe pre-exiting diseases :autoimmune diseases, an active
infectious diseases, cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, and hematological disorders.
2.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner
3.No active brain metastases.
4.Patients who should receive systemic administration of steroid or
immunosuppressive agents.
5.Inappropriate for study entry judged by an attending physician.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Kenzaburo Tani

Organization

Kyushu University Hospital

Division name

Department of Advanced Molecular and Cell Therapy

Zip code

Address

3-1-1 Maidashi, Higashiku, Fukuoka-shi, 812-8582, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Yasuki Hijikata

Organization

Kyushu University Hospital

Division name

Department of Advanced Molecular and Cell Therapy

Zip code

Address

3-1-1 Maidashi, Higashiku, Fukuoka-shi, 812-8582, Japan

TEL

092-642-5996

Homepage URL

Email

Institute

Kyushu University Hospital

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

07

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2009

Year

03

Month

19

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

07

Month

25

Day

Last modified on

2014

Year

09

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004749