Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.

Detailed Description
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CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.

Official Title
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Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Biological: CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry Refractory or relapsed B cell-acute lymphoblastic leukemia No available curative treatment options (such as hematopoietic stem cell transplantation) Stage III-IV disease Creatinine < 2.5 mg/dl Aspartate transaminase-alanine transaminase ratio < 3x normal Bilirubin < 2.0 mg/dl Karnofsky performance status >= 60 Expected survival time > 3 months Adequate venous access for apheresis Ability to understand and provide informed consent Exclusion Criteria: Pregnant or lactating women Patients requiring T cell immunosuppressive therapy Active central nervous system leukemia Any concurrent active malignancies Patients with a history of a seizure disorder or cardiac disorder Patients with human immunodeficiency virus, hepatitis B or C infection Uncontrolled active infection

Ages Eligible for Study
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Minimum Age: 18 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: CAR-T cells<br>Targeting CD19 | Biological: CAR-T cells<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical responses to third generation CAR-T cells | To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia | 2 years |