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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031853
Receipt No. R000035766
Scientific Title Investigator-initiated multi-institutional phase I clinical trial of NY-ESO-1-specific TCR gene-modified T cell therapy for adult T cell leukemia/lymphoma patients relapsed after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2018/03/23
Last modified on 2021/10/08

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Basic information
Public title Investigator-initiated multi-institutional phase I clinical trial of NY-ESO-1-specific TCR gene-modified T cell therapy for adult T cell leukemia/lymphoma patients relapsed after allogeneic hematopoietic stem cell transplantation
Acronym A phase 1 investigator-initiated study of TBI-1301-A for refractory ATLL experiencing recurrence after allo-HSCT
Scientific Title Investigator-initiated multi-institutional phase I clinical trial of NY-ESO-1-specific TCR gene-modified T cell therapy for adult T cell leukemia/lymphoma patients relapsed after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym A phase 1 investigator-initiated study of TBI-1301-A for refractory ATLL experiencing recurrence after allo-HSCT
Region
Japan

Condition
Condition Refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 NY-ESO-1-specific TCR gene transduced donor-derived T lymphocytes (TBI-1301-A) are transfused to HLA-A*02:01 or HLA-A*02:06 positive
and NY-ESO-1 expressing patients with refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation. The objective is to evaluate the safety, pharmacokinetics of TBI-1301-A, clinical effects, and GVHD severity in this gene therapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
- Frequency of occurring adverse event
- Frequency of occurring product failure
- Appearance of replication competent retrovirus (RCR)
- Appearance of clonality
Key secondary outcomes 1) Pharmacokinetics of blood TBI-1301-A
2) Clinical effects
3) Transition of laboratory test values
4) Appearance and severity of GVHD

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
Medicine Gene
Interventions/Control_1 TBI-1301-A is transfused once after pretreatment by cyclophosphamide
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients:
1) Patient with refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation from his/her relative or from an unrelated individual registrated in Japan Marrow Donor Program (JMDP)
2) HLA-A*02:01 or HLA-A*02:06 positive
3) NY-ESO-1-expression in tumor-infiltrated tissue (skin, lypph node, etc) or peripheral blood by immunohistochemistry or PCR
4) (Only secondary registration) Having a donor who matches eligibility criteria
5) ECOG Performance Status, 0 ~ 2
6) Age >=20 years on consent
7) Life expectancy >= 12 weeks after consent
8) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria;
T. billirubin < 3 x ULN
AST(GOT), ALT(GPT) < 5 x ULN
Creatinine < 3 x ULN
LVEF >=55%
SpO2 >=94%
9) (only secondary registration) Completion of TBI-1301-A preparation
10) Ability to understand the study contents and to give a written consent at his/her free will

Donor:
1) Original donor of hematopoetic stem cell transplantation
2) Age >=20 (20<= Age <=57, in case of an unrelated person coordinated by JMDP) years on consent
3) Ability to understand the study contents and to give a written consent at his/her free will
Key exclusion criteria Patients:
1) The following serious complications 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) Serious hypersensitivity
3) Tumor cell invasion into CNS
4) Active multiple cancer
5) History of serious hypersensitivity reactions to bovine or murine derived substances, human serum albumin, streptomycin sulfate or amphotericin B
6) History of hypersensitivity reaction to drugs used in this study
7) Recurrence within 30 days after hematopoietic stem cell transplantation
8) GVHD >= Grade 3 (based on the guideline given JSHCT)
9) Uncontrollable pleural effusion, ascites or pericardial effusion
10) Antitumor therapy (chemotherapy, molecular targeted therapy, immunotherapy, radiation therapy, etc.) which are performed or will be performed within 4 weeks prior to the pre-treatment
11) Psycological disorder or drug dependency which may have impact on the consent
12) Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to at lease 6 months after the transfusion of TBI-1301-A
13) Any other inadequacy for this study

Donor:
1) Positvity fo any of HBs antigen, HBV-DNA, HCV antibody, HCV-RNA, HIV antibody, HIV-RNA, serologic test of syphilis and parvovirus B19-DNA
2) Psycological disorder or drug dependency which may have impact on the consent
3) Any other inadequacy for this study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ikeda
Organization Graduate School of Biomedical Sciences, Nagasaki University
Division name Department of Oncology
Zip code 852-8523
Address 1-12-4 Sakamoto, Nagasaki-city, Nagasaki
TEL 095-819-7079
Email hikeda@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Tatsushi
Middle name
Last name Goto
Organization Secretariat of clinical trial coordinating committee
Division name none
Zip code 530-0044
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka
TEL 06-6358-7110
Homepage URL
Email gotou@fiverings.co.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Hospital IRB
Address 1-7-1 Sakamoto, Nagasaki-city, Nagasaki, 852-8501, Japan
Tel -
Email -

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-183830
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 獨協医科大学病院(栃木県)、東京大学医科学研究所附属病院(東京都)、名古屋市立大学病院(愛知県)、三重大学医学部附属病院(三重県)、大阪国際がんセンター(大阪府)、九州大学病院(福岡県)、長崎大学病院(長崎県)、鹿児島大学病院(鹿児島県)、今村総合病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 23 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 1
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 Terminated
Date of protocol fixation
2017 Year 09 Month 11 Day
Date of IRB
2017 Year 12 Month 22 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2021 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
2018 Year 03 Month 23 Day
Last modified on
2021 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035766

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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