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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029573
Receipt No. R000033661
Scientific Title Multi-center Phase I/II Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes following chemotherapy pre-treatment in Patients with Synovial Sarcoma
Date of disclosure of the study information 2017/10/16
Last modified on 2019/04/25

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Basic information
Public title Multi-center Phase I/II Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes following chemotherapy pre-treatment in Patients with Synovial Sarcoma
Acronym Phase I/II Study of TBI-1301 in Patients with Synovial Sarcoma
Scientific Title Multi-center Phase I/II Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes following chemotherapy pre-treatment in Patients with Synovial Sarcoma
Scientific Title:Acronym Phase I/II Study of TBI-1301 in Patients with Synovial Sarcoma
Region
Japan

Condition
Condition Synovial sarcoma
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The efficacy and the safety of TBI-1301 (NY-ESO-1 specifc TCR gene transferred autologous T lymphocytes) are evaluated in HLA-A*02:01 or HLA-A*02:06 positive patients with relapsed synovial sarcoma, which are surgically unresectable, refractory to anthracycline therapy, and NY-ESO-1-expressing.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes [Phase I portion]
Adverse event, mortality, severe adverse event, discontinuation due to adverse event, laboratory test values
Appearance of clonality by LAM-PCR
Blood kinetics of TBI-1301 by realtime-PCR

[Phase II portion]
Overall response rate
Key secondary outcomes [Phase I portion]
Objective response rate
Progression free rate at week 12
Progression free survival
Overall survival

[Phase II portion]
Progression free rate
Progression free survival
Overall survival
Adverse event, mortality, severe adverse event, discontinuation due to adverse event, laboratory test values
Appearance of RCR
Appearance of clonality (LAM-PCR)
Blood kinetics of TBI-1301

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
Medicine Gene
Interventions/Control_1 As pretreatment, Cyclophosphamide (750 mg/m2) is administered intravenously once a day on day -3 and -2 for 2 days. Split dose of TBI-1301 (5 x 10^9 cells [+-30%]) is administered intravenously on day 0 and 1 for 2 days.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed synovial sarcoma
2) Surgically unresectable tumor
3) Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracyclin
4) HLA-A*02:01 or HLA-A*02:06 positive
5) Tumor that express NY-ESO-1 by immunohistochemistry
6) >= 18 years of age
7) Measurable lesions that are expected to be evaluable by the RECIST ver1.1
8) ECOG Performance Status of 0, 1 or 2
9) No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing
10) Life expectancy >= 16 weeks after consent
11) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria;
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- AST(GOT), ALT(GPT) < 3.0 x ULN
- Creatinine < 1.5 x ULN
- 2,500/microL < WBC =< ULN
- Hemoglobin >= 8.0g/dL
- Platelets >= 75,000/microL
12) Patients must be able to understand the study contents and to give a written consent at his/her free will. Additionally, if patients are below 20 years of age, proxies must be able to give a written consent.
Key exclusion criteria 1) Patients with the following conditions are excluded from the study;
- Unstable angina, cardiac infarction, or heart failure
- Uncontrolled diabetes or hypertension
- Active infection
- Obvious interstitial pneumonia or lung fibrosis by chest X-ray
- Active autoimmune disease requiring steroids or immunosuppressive therapy.
2) Active metastatic tumor cell invasion into CNS
3) Active multiple cancer
4) Positive for HBs antigen or HBV-DNA observed in serum
5) Positive for HCV antibody and HCV-RNA observed in serum
6) Positive for antibodies against HIV or HTLV-1
7) Left Ventricular Ejection Fraction (LVEF) =< 50%
8) History of serious hypersensitivity reactions to bovine or murine derived substances.
9) History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study
10) History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.
11) Pregnant females, lactating females (except when they cease and do not resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to 6 months after infusion of the investigational drug.
12) Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Takahashi
Organization Takara Bio Inc.
Division name Project Management Department
Zip code
Address Nojihigashi 7-4-38, Kusatsu, Shiga, Japan
TEL 077-565-6976
Email takahashisz@takara-bio.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name NA
Organization Takara Bio Inc.
Division name PR/IR Department
Zip code
Address Nojihigashi 7-4-38, Kusatsu, Shiga, Japan
TEL 077-565-6970
Homepage URL
Email takara-clinical@takara-bio.co.jp

Sponsor
Institute Takara Bio Inc.
Institute
Department

Funding Source
Organization Takara Bio Inc.
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-173514
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2 NCT03250325
Org. issuing International ID_2 U.S. National Library of Medicine
IND to MHLW

Institutions
Institutions 三重大学医学部附属病院(三重県)、国立病院機構大阪医療センター(大阪府)、札幌医科大学附属病院(北海道)、九州大学病院(福岡県)、国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 16 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 13 Day
Date of IRB
2017 Year 08 Month 16 Day
Anticipated trial start date
2017 Year 09 Month 20 Day
Last follow-up date
2020 Year 01 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
2017 Year 10 Month 16 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033661

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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