UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030984 |
|---|---|
| Receipt number | R000035020 |
| Scientific Title | Phase I study of piggyBac transposon mediated chimeric antigen receptor gene modified T cells for CD19 positive acute lymphoblastic leukemia |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2020/07/27 10:42:06 |
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Basic information
Public title
Phase I study of piggyBac transposon mediated chimeric antigen receptor gene modified T cells for CD19 positive acute lymphoblastic leukemia
Acronym
piggyBac transposon mediated chimeric antigen receptor gene modified T cells for CD19 positive acute lymphoblastic leukemia
Scientific Title
Phase I study of piggyBac transposon mediated chimeric antigen receptor gene modified T cells for CD19 positive acute lymphoblastic leukemia
Scientific Title:Acronym
piggyBac transposon mediated chimeric antigen receptor gene modified T cells for CD19 positive acute lymphoblastic leukemia
Region
| Japan |
Condition
Condition
refractory/relapsed CD19 positive acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate tolerability and safety of piggyBac transposon mediated chimeric antigen receptor modified T cells (CAR-T) for CD19 positive acute lymphoblastic leukemia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence of DLT until 4 weeks after CAR-T infusion
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Administration of CAR-T cells produced from autologous peripheral blood
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
| 1 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) CD19 positive ALL
2) chemo-refractory/relapsed after allogeneic stem cell transplantation
3) 1-60 years old*
4) Written informed consent from patient or legal representative
5) Fulfill all of the following criteria:
i) Performance status (PS) score: 0-3
ii) AST=<5 x upper normal limit (UNL)
iii) ALT=<5 x UNL
iv) total bilirubin =<3 x UNL
v) serum creatinine =<3 x UNL
vi) SpO2>=90% (room air)
*Cohort 1: 16-60 years old, Cohort 2: 1-15 years old
Key exclusion criteria
1) predonisolone use >=0.5 mg/kg
2) BM blast >=20%
3) CNS-3
4) isolated extramedullary leukemia
5) severe or uncontrollable infection
6) severe or uncontrollable GVHD
7) severe or uncontrollable heart failure
8) previous use of CAR-T therapy
9) previous use of CD3/CD19 bispesific antibody
10) Psychoses
11) History of allergic reaction to albumin
12) History of allergic reaction to mouse derived protein
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2942
ytakaha@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nishio |
Organization
Nagoya University Hospital
Division name
Center for Advanced Medicine and Clinical Research
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2942
Homepage URL
nnishio@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Second Certified Special Committee for Regenerative Medicine, Osaka University
Address
4F Center of Medical Innovation and Translational Research 2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8293
nintei@dmi.med.osaka-u.ac.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 | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035020
