UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029573
Receipt number 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 2023/10/31 10:01:14

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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 Shuichi
Middle name
Last name Takahashi

Organization

Takara Bio Inc.

Division name

Regenerative Medical Products Manufacturing

Zip code

525-0058

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 NA
Middle name
Last name NA

Organization

Takara Bio Inc.

Division name

Corporate Development

Zip code

525-0058

Address

Nojihigashi 7-4-38, Kusatsu, Shiga, Japan

TEL

077-565-6970

Homepage URL


Email

takara-clinical@takara-bio.co.jp


Sponsor or person

Institute

Takara Bio Inc.

Institute

Department

Personal name



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

Mie University Hospital IRB

Address

2-174, Edobashi, Tsu, Mie, 514-8507

Tel

059-231-5246

Email

crsc@clin.medic.mie-u.ac.jp


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

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/37792433/

Number of participants that the trial has enrolled

8

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

Completed

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

2034 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

2023 Year 10 Month 31 Day



Link to view the page

Value
https://center6.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