Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)

Study Overview
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Brief Summary
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Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.

Detailed Description
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Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia and determine the best dosage.

Official Title
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Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients

Conditions
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Leukemia

Intervention / Treatment
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* Biological: IM19 CAR-T
* Drug: fludarabine and cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens） To be aged 3 to 75 years Blast in blood ≤ 30% ECOG score ≤2 Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time. Voluntary participation in the clinical trials and sign the informed consent. Exclusion Criteria: Intracranial hypertension or unconsciousness Respiratory failure CD19 negative Disseminated intravascular coagulation ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x normal value Hematosepsis or Uncontrolled active infection Uncontrolled diabetes Abalienation; WHO Sscore >3 Patients in pregnancy or breast-feeding period Previously treatment with any gene therapy products Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 75 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: IM19 CART<br>All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later. | Biological: IM19 CAR-T<br>* T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor<br>* Other names: IM19;Drug: fludarabine and cyclophosphamide<br>* Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days<br>* Other names: FC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry | 2 years |