B-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Status | Recruiting |
Enrollment | 18 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility |
Inclusion Criteria: 1. More than 1 year; 2. CD19 positive B-cell acute lymphoblastic leukemia; 3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction =50%, no obvious abnormality in ECG; blood oxygen saturation =90%; creatinine clearance calculated by Cockcroft-Gault formula =40ml/min; ALT and AST= 5 times normal range, total bilirubin = 34.2 µmol / L. 4. Expected to survive for more than 3 months; 5. Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: 1. Recent or current use of glucocorticoid or other immunosuppressor; 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive; 3. Has a graft-versus-host response and requires the use of immunosuppressants; 4. Drug uncontrollable central nervous system leukemia; 5. Pregnant or lactating female; 6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year; 7. A history of other malignant tumors; 8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study. |
Country | Name | City | State |
---|---|---|---|
China | Hebei Yanda Ludaopei Hospital | Langfang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Tianjin Mycure Medical Technology Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of adverse events | Percentage of participants with adverse events | 6 months | |
Secondary | complete remission rate | The percentage of participants who achieved complete remission (CR) over all participants (CRR). | 6 months | |
Secondary | objective remission rate | The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR). | 6 months |
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