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
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
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
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
