- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975687
CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia
July 7, 2019 updated by: wang, jianxiang, Institute of Hematology & Blood Diseases Hospital
In this single-center, open-label, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled.
CD19 CAR T cells will be administered by i.v.
injection as a using a "split dose" (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled.
Patients will be diagnosed according to morphologic, immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular examination.
CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB,administered by i.v.
injection as a using a "split dose" (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2.
This protocol will be given to subjects with unmet medical needs for which there are no effective therapies known at this time.
Side effects of CD19 CAR T cells therapy will be monitored.
The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with chemotherapy resistant or refractory CD19+ ALL.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tianjin, China, 300020
- Institute of Hematology & Blood Diseases Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 18 to 70 years with relapsed or refractory CD19 positive ALL(ie, ≥20% blasts CD19-positive) due to receive either salvage 1 or salvage 2 therapy. Ph+ ALL patients must have failed treatment with at least 1 second generation tyrosine kinase inhibitor.
- Bone marrow involvement with≥20% lymphoblasts.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal(ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
- Patients should sign informed consent form.
Exclusion Criteria:
- Isolated extramedullary relapse.
- Active central nervous system leukemia.
- Prior chemotherapy within ≤2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine, thioguanine, and tyrosine kinase inhibitors are permitted within 2 weeks of enrollment as maintenance or to reduce the peripheral blood blast count. Patients must have recovered from acute toxicity of all previous therapy prior to enrollment.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have > grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
- Peripheral lymphoblasts > 10,000/μl (treatment with hydroxyurea and/or steroids is permitted within 2 weeks of enrollment to reduce the WBC count).
- Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
- Major surgery within ≤ 4 weeks before enrollment.
- Impaired cardiac function:Ejection fraction < 45 % on MUGA scan. QTc interval > 450 msec on baseline ECG (using the QTcB formula). If QTcB interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
- Administration of live vaccine ≤ 4 weeks before enrollment.
- Other concurrent severe and/or uncontrolled medical conditions:
Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
- Evidence of uncontrolled current serious active infection.
- Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Who is known human deficiency virus (HIV) positive.
- Use of any other investigational agent in the last 30 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
CD19 CAR T cells will be administered by i.v.
injection as a using a "split dose" (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2.
|
CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The complete remission (CR) rate
Time Frame: Participants will be followed for the duration of the treatment, an expected average of 12 months.
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Participants will be followed for the duration of the treatment, an expected average of 12 months.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free survival (DFS)
Time Frame: From the date of complete remission(CR) until the date of documented relapse,assessed up to 60 months.
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From the date of complete remission(CR) until the date of documented relapse,assessed up to 60 months.
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Number of adverse event of CD19 CAR T cells treatment
Time Frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
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Participants will be followed for the duration of the treatment, an expected average of 24 months.
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Grade of adverse event of CD19 CAR T cells treatment
Time Frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
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Participants will be followed for the duration of the treatment, an expected average of 24 months.
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Duration of in vivo survival of CD19 CAR T cells.
Time Frame: Participants will be followed for the duration of the treatment, an expected average of 24 months.
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Participants will be followed for the duration of the treatment, an expected average of 24 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 7, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-CD19CART-001
- HY001001 (Other Identifier: Juventas Cell Therapy Ltd.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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