CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

Study Overview
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Brief Summary
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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).

Detailed Description
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In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. 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 R/R B-ALL.

Official Title
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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)

Conditions
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B-cell Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Biological: CD19 CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 1 year; CD19 positive B-cell acute lymphoblastic leukemia; 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. Expected to survive for more than 3 months; Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: Recent or current use of glucocorticoid or other immunosuppressor; Uncontrolled active infection, HIV infection, syphilis serology reaction positive; Has a graft-versus-host response and requires the use of immunosuppressants； Drug uncontrollable central nervous system leukemia； Pregnant or lactating female； The patient did not agree to use effective contraception during the treatment period and for the following 1 year； A history of other malignant tumors; 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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-center, open-label, nonrandomized, no control, prospective clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD19-CAR-T Cells<br>Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose. | Biological: CD19 CAR-T cells<br>* T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adverse events | Percentage of participants with adverse events | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | The percentage of participants who achieved complete remission (CR) over all participants (CRR). | 6 months | 
| objective remission rate | The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell acute lymphoblastic leukemia, CD19 CAR-T