A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
NCT ID: NCT02968472
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2015-03-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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prophylactic 4SCAR19 cells
Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
prophylactic 4SCAR19 cells
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Interventions
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prophylactic 4SCAR19 cells
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Eligibility Criteria
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Inclusion Criteria
* the immune phenotype analysis of patients with malignant B cell surface expression CD19 molecules.
* the Karnofsky performance status score over 80 points, is expected to patients survival time is more than 3 months.
* the important viscera function meet: heart ultrasound tip heart ejection fraction 50% or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate aminotransferase and aspartate aminotransferase3 times normal range or less, total bilirubin of 2.0 mg/dl or less.
* or greater Hgb 80 g/L.
* no contraindications to solid and cell separation
* the patient and family to have a strong willingness to participate in clinical trials, and are willing to bear all the consequence caused by the test failed, and sign the informed consent.
* the panel discussion, combined with patient general condition, think the benefit is greater than the risks involved in the clinical trials.
Exclusion Criteria
* bacteria, fungus, or virus infection, unable to control.
* people living with HIV.
* active hepatitis B virus and hepatitis C virus infection.
* of pregnancy and nursing mothers.
* before entering the test of the use of glucocorticoid systemic treatment within a week.
* confirmed before used CAR - but invalid patients treated T cells, after in the physical examination, experts discuss confirmed by a team doesn't fit in the CAR again - T treatment.Before used gene therapy method.
* the researchers believe that might increase risk subjects or interfere with the test results of any situation.
6 Months
ALL
No
Sponsors
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Shenzhen Geno-Immune Medical Institute
OTHER
The First People's Hospital of Yunnan
OTHER
Responsible Party
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Xun Lai
chief physician
Principal Investigators
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Huang Jianzhang, Doctor
Role: STUDY_CHAIR
Shenzhen immune gene therapy research institute
Locations
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First people's hospital of Yunnan province
Kunming, Yunnan, China
Countries
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Central Contacts
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References
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Lai X, Sun YY, Chang LJ, Ma YR, Gu XZ, Yao XM, Nie B, Wen Y, Zhang XM, Jiang YX, Yang H, Yu LQ, Fang MJ, Wang L, Yuan Bo X. Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy? Bioengineered. 2020 Dec;11(1):824-828. doi: 10.1080/21655979.2020.1791597.
Other Identifiers
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LXUN
Identifier Type: -
Identifier Source: org_study_id