UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035020
Receipt number R000039932
Scientific Title Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.
Date of disclosure of the study information 2018/11/27
Last modified on 2021/12/21 15:05:50

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Basic information

Public title

Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.

Acronym

Vaccination with neoantigen-loaded DCs

Scientific Title

Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.

Scientific Title:Acronym

Vaccination with neoantigen-loaded DCs

Region

Japan


Condition

Condition

Malignant tumor (except leukemia)

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Nephrology Neurology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Endocrine surgery Breast surgery Obstetrics and Gynecology
Pediatrics Ophthalmology Dermatology
Oto-rhino-laryngology Urology Oral surgery
Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Safety

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Safety

Key secondary outcomes

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

Vaccine

Interventions/Control_1

neoantigen peptides-loaded (autologous) dendritic cells

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

12 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

A patient must:

- have ECOG Performance Status of 0, 1 and 2.

- maintain adequate function of key organs when the eligibility is confirmed, in particular:

1. haemoglobin 8.0 g/dl or more
2. platelet 50.000 /mm3 or more
3. total bilirubin 3 x ULN or more
4. AST/ALT 3 x ULN or less
5. creatinine 3 x ULN or less

- provide written consent for genetic analysis of tumor sample; neoantigen-screening analysis, and for treatment of those neoantigens-loaded DC vaccination.

- have a proper mental condition and an ability to recognize the object and contents of the study when informed consent is obtained.


Key exclusion criteria

A patient must not:

- be impossible to obtain blood sample by Leukapeheresis.

- be positive in HIV antibody test.

- have active auto-immune disorder.

- have serious underlying disease.

- be pregnant (including pregnancy seeker)

- be judged ineligibles by clinician in this trial.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Keishi
Middle name
Last name Tanigawa

Organization

Bio-Thera Kai,Non-profit medicalcorporation

Division name

Bio-Thera Clinic

Zip code

1600022

Address

5-6-12 Shinjyuku, Sinjyukuku, Tokyo 1600055 Japan

TEL

03-5919-1762

Email

tanigawa@bio-c.jp


Public contact

Name of contact person

1st name Yasunobu
Middle name
Last name Kobayashi

Organization

Bio-Thera Kai,Non-profit medicalcorporation

Division name

Bio-Thera Clinic

Zip code

1600022

Address

5-6-12 Shinjyuku, Sinjyukuku, Tokyo 1600055 Japan

TEL

03-5919-1762

Homepage URL


Email

ykobayashi@bio-c.jp


Sponsor or person

Institute

Bio-Thera Clinic

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Bio-Thera Clinic IRB

Address

5-6-12 Shinjyuku, Shinjyuku-ku, Tokyo 1600022 Japan

Tel

0359191761

Email

info@bio-c.jp


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

2018 Year 11 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

19

Results

Neoantigen DCs would be a safe treatment method.

Neoantigen DCs would induce the acquisition of immune reaction against neoantigens.

Results date posted

2021 Year 12 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with solid carcinoma who implemented the inclusion criteria of this study were eligible for enrollment in this prospective study. After patients had received a full explanation according to the protocol, they were requested to provide informed consent to participate in this study.

From August 06, 2018 to August 05, 2021, a total 20 patients were enrolled in this study.

The patient characteristics was as follows: median age, 51.5 (range 32 - 68) years; sex (male: female) = 11: 9; primary lesion (brain, nasopharynx, breast, lung, stomach, jejunum, colon, rectum, liver, biliary duct, pancreas, uterine cervix, bladder, and soft tissue) = 2, 1, 2, 1, 1, 1, 2, 2, 1, 1, 3, 1, 1, and 1, respectively.

Fifteen and 4 patients had undergone surgery and radiotherapy before this study, respectively.

Chemotherapy was concurrently performed in 15 patients while they participated in this study.

Participant flow

The 20 patients were vaccinated weekly for 8 times with neoantigen pulsed dendritic cells (neoantigen DCs) plus ex-vivo activated T-cell transfer.

The primary endpoint was to evaluate the safety of neoantigen DCs, which was determined with physical exams and blood tests. Blood tests were performed, before 1st, after 4th, and 8th administration of neoantigen DCs.

The secondary endpoint was to evaluate the acquisition of immune reaction against neoantigens after intradermal administration of neoantigen DCs. It was determined by confirming redness and induration of the skin (Delayed-type hypersensitivity (DTH)) at injection site 48 hours from administration of neoantigen DCs.

One of the 20 patients withdrew after 7th administration.

Remaining 19 patients completed the original protocol.

Adverse events

Adverse events were observed in 11 patients as follows: adverse events (reduction of hemoglobin, reduction in hemoglobin number, increase in AST level, increase in total bilirubin level, appetite loss, and fatigue) = 8, 1, 2, 1, 3, and 5, respectively. JCOG-CTCAE (v5.0) grade was as follows: grade (1: 2: 3) = 4: 10: 6. All patients with adverse events underwent concurrent chemotherapy. We considered all adverse events were related to drug toxicity of chemotherapy.

One of the 20 patients withdrew after 7th administration because of refractory liver abscess and severe pneumonia which were considered to be a postoperative complication and an adverse event derived from chemotherapy.

Outcome measures

Concerning the primary endpoint, no adverse events associated to neoantigen DCs were observed.

Concerning the secondary endpoint, DTH was observed in 19 patients whereas it was negative in 1 case with cervical cancer. This patient had intractable pelvic abscess as an adverse after surgery and radiotherapy, and that would prevented DTH.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 08 Month 06 Day

Date of IRB

2018 Year 05 Month 21 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2021 Year 09 Month 10 Day

Date of closure to data entry

2021 Year 09 Month 10 Day

Date trial data considered complete

2021 Year 09 Month 10 Day

Date analysis concluded

2021 Year 09 Month 10 Day


Other

Other related information

The costs associated with several treatments and examinations in this study shall be borne by each patient.


Management information

Registered date

2018 Year 11 Month 27 Day

Last modified on

2021 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039932


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name