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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name