A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
1 other identifier
interventional
30
1 country
1
Brief Summary
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically， which summarizes the best therapeutic effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedNovember 18, 2016
November 1, 2016
4.2 years
November 16, 2016
November 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
24 weeks
Secondary Outcomes (1)
Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)
1 year
Study Arms (1)
prophylactic 4SCAR19 cells
EXPERIMENTALPatients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
Interventions
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Eligibility Criteria
You may qualify if:
- patients aged more than 6 months.
- 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.
You may not qualify if:
- accompanied with other active disease, the treatment is difficult to correct.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First people's hospital of Yunnan province
Kunming, Yunnan, NCT650000, China
Related Publications (1)
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.
PMID: 32772769DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huang Jianzhang, Doctor
Shenzhen immune gene therapy research institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 18, 2016
Study Start
March 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
November 18, 2016
Record last verified: 2016-11