UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015617
Receipt No. R000018149
Scientific Title Clinical Research of gene therapy for relapsed or refractory B-cell Non-Hodgkin Lymphoma using autologous T cells expressing a chimeric antigen receptor specific to the CD19 antigen
Date of disclosure of the study information 2014/11/06
Last modified on 2014/11/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical Research of gene therapy for relapsed or refractory B-cell Non-Hodgkin Lymphoma using autologous T cells expressing a chimeric antigen receptor specific to the CD19 antigen
Acronym Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes
Scientific Title Clinical Research of gene therapy for relapsed or refractory B-cell Non-Hodgkin Lymphoma using autologous T cells expressing a chimeric antigen receptor specific to the CD19 antigen
Scientific Title:Acronym Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes
Region
Japan

Condition
Condition Relapsed/Refractory CD19+ B-NHL
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes # Quality test of anti-CD19 CAR expressing T cells (CD19-CAR-T)
# Safety: Adverse events, laboratory tests (hematology, serum chemistry, immunological, and infectious disease)
# Replication competent retrovirus (RCR) test
# Linear amplification mediated-PCR (LAM-PCR)
Key secondary outcomes # Antitumor effect of CD19-CAR-T
# Lymphocyte subset analysis of CD19-CAR-T
# Immunogenicity of CD19-CAR-T

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
Interventions/Control_1 # Dose level -1; 0-6 patients
1. Pre-treatment: Cyclophosphamide
1.5 g/m^2 * 1 day i.v. (Day -2)
or Bendamustine
120 mg/m^2 * 2 days i.v.
(Day -3, Day -2)
2. Infusion of CD19-CAR-T cells
3 * 10^5 cells/kg, a split dose
(Day 0: 1/3 dose, Day 1: 2/3 dose)

# Dose level 1(Starting Dose);
3-6 patients
1. Pre-treatment: Cyclophosphamide
1.5 g/m^2 * 1 day i.v. (Day -2)
or Bendamustine
120 mg/m^2 * 2 days i.v.
(Day -3, Day-2)
2. Infusion of CD19-CAR-T cells
1 *10^6 cells/kg, a split dose
(Day 0: 1/3 dose, Day 1: 2/3 dose)

# Dose level 2; 0-6 patients
1. Pre-treatment: Cyclophosphamide
1.5 g/m^2 * 1 day i.v. (Day -2)
or Bendamustine
120 mg/m^2 * 2 days i.v.
(Day -3, Day-2)
2. Infusion of CD19-CAR-T cells
3 * 10^6 cells/kg, a split dose
(Day 0: 1/3 dose, Day 1: 2/3 dose)

# Dose level 3; 0-6 patients
1. Pre-treatment: Cyclophosphamide
1.5 g/m^2 * 1 day i.v. (Day -2)
or Bendamustine
120 mg/m^2 * 2 days i.v.
(Day -3, Day-2)
2. Infusion of CD19-CAR-T cells
1 *10^7 cells/kg, a split dose
(Day 0: 1/3 dose, Day 1: 2/3 dose)
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Relapsed or refractory B-NHL.
2. Evaluable region can be identified by CT scan and is positive by FDG-PET.
3. 20<= age <=70 years at the time of informed consent.
4. ECOG performance status of 0-2
5. Well preserved main organ function below.
1) Neutrophil count >=1,500/micro liter
(excluded: neutropenia due to marrow infiltration of lymphoma)
2) Platelet count >= 10*10^4/micro liter
(excluded: thrombocytopenia due to bone marrow infiltration of lymphoma)
3) T-bil <= 2.0 mg/dL
(excluded: the abnormally value due to hepatobiliary of lymphoma)
4) ALT (GPT)/AST (GOT) <= 150 IU/dL
(excluded: the abnormally value due to hepatic infiltration of lymphoma)
5) ALP <= 1.5 * upper limit of normal (ULN)
(excluded: the abnormally value due to hepatobiliary of lymphoma)
6) Serum creatinine <= 2.0 mg/dL
7) SpO2 >= 92% (without oxygen inhalation)
6. Life expectancy >= 3 months after informed consent.
7. Written informed consent.
Key exclusion criteria 1. Other active malignancy.
2. CNS infiltration of lymphoma.
3. History of allogeneic stem cell transplantation.
4. Already participated in a clinical trial in which CD19-CAR-T are administered within 24 weeks.
5. Concurrent use of systemic steroids or immunosuppressive agents.
6. Concurrent severe heart disease
7. History of severe cerebrovascular disease or sequela including paralysis
8. Known active or severe infection.
9. HIV seropositive status
10. HBsAg-positive or both HBcAb and HBV-DNA positive.
11. Active hepatitis C.
12. Psychiatric disorder or drug addiction that affects the ability of informed consent.
13. Pregnant or breastfeeding women, women who may be pregnant and women desiring to become pregnant. Men who desire impregnating a woman are also excluded(excluded: in case when sperm is cryopreserved prior to gene therapy and a child is born by using the sperm).
14. Any other patients judged by the investigators to be inappropriate for the subject of this study.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiya Ozawa
Organization Jichi Medical University
Division name Division of Immuno-Gene& Cell Therapy(Takara Bio)
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7353
Email kozawa@ms2.jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Ohmine
Organization Jichi Medical University
Division name Division of Immuno-Gene& Cell Therapy(Takara Bio)
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7353
Homepage URL
Email omineken@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Takara Bio Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Takara Bio Inc.
Name of secondary funder(s) Jichi Medical University

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02134262
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 06 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 06 Day
Last modified on
2014 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.