A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

Study Overview
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Brief Summary
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Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.

Official Title
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A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.

Conditions
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B Cell Leukemia, B Cell Lymphoma

Intervention / Treatment
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* Biological: ICAR19 CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD19 positive leukemia and lymphoma，relapsed and/or refractory： survival>12 weeks; FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin; LVEF≥50%; Creatinine<2.5mg/dl; Bilirubin<2.5mg/dl; ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal; At least 7 days after last chemotherapy; provide with informed consent. Exclusion Criteria: Active clinically significant CNS dysfunction Pregnant or breast-feeding women. Uncontrolled active infection including hepatitis B or C. HIV positive. Use of systemic steroids within 72 hours. Allogeneic lymphocyte treatments within recent 6 months. Any uncontrolled active medical disorder.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 80 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: ICAR19 CAR-T cells<br>Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells. | Biological: ICAR19 CAR-T cells<br>* T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.<br>* Other names: Biological drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the safety of ICAR19 CAR-T cells | To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the anti-tumor effect of ICAR19 CAR-T cells | Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma | 3 years | 
| Survival time of ICAR19 T cells in vivo. | To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time | 5 years |