CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Study Overview
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Brief Summary
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This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Detailed Description
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The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Official Title
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Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Conditions
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Leukemia, B-cell

Intervention / Treatment
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* Biological: CART-19/22


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows: Age 6-65 years. Left ventricular ejection fractions≥ 0.5 by echocardiography. Creatinine < 1.6 mg/dL. Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal. Bilirubin <2.0 mg/dL. Karnofsky performance status ≥ 60 Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: Pregnant or lactating women. Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Class III/IV cardiovascular disability according to the New York Heart Association Classification. HIV infection. Patients with history of seizure Active central nervous system leukemia

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. | Biological: CART-19/22<br>* Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19/22 cells/kg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Adverse events are evaluated with CTCAE V4.03 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD19, CD22