CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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Relapsed and refractory B cell acute lymphoblastic leukemia (B-ALL) shows unfavorable prognosis, especially for adult patients. Besides, minimal residual disease (MRD) positive at transplant has been considered risk factor for relapse after transplantation. Worse yet, there is no standard management for these patients. Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with CD19+ ALL.

Official Title
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CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia

Conditions
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Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Adult

Intervention / Treatment
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* Biological: CD19-CAR-T2 Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with CD19 positive B-cell acute leukemia Eastern Cooperative Oncology Group (ECOG) performance status <2 ALT/ AST <3 x normal Bilirubin < 2.0 mg/dl Creatinine < 2.5 mg/dl and less than 2.5x normal for age LVEF< 45% Accept white blood cell collection Provide informed consent Exclusion Criteria: Previous treatment with investigational gene or cell therapy medicine products Active hepatitis B , hepatitis C or HIV infection Uncontrolled active infection Presence of grade 2-4 acute or extensive chronic GVHD Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma, Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc. Any uncontrolled active medical disorder that would preclude participation as outlined. Received non-diagnostic purposes major surgery within the past 4 weeks Participated in any other clinical study within the past 4 weeks Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. Pregnancy or breast-feeding women Use of prohibited drugs: Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion Any situation that may increase the risk of the test or interfere with the test results

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 group<br> | Biological: CD19-CAR-T2 Cells<br>* CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR |  | 6 months | 
| ORR |  | 12 months | 
| Adverse Events |  | 12 months | 
| OS | overall survival | 1 year | 
| DFS | disease-free survival | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute lymphoblastic leukemia, minimal residual disease, CAR-T