UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015617 |
|---|---|
| Receipt number | 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 14:19:16 |
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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
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
omineken@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018149
