A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies

Inclusion Criteria:

• Inclusion criteria only for B-ALL:

1. Histologically confirmed diagnosis of CD19+ B-ALL per the US NationalComprehensive Cancer Network (NCCN) Clinical Practice Guidelines for AcuteLymphoblastic Leukemia (2016.v1)；
2. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
3. CR not achieved after standardized chemotherapy;
4. CR achieved following the first induction, but CR duration is less than 12months;
5. Ineffectively after first or multiple remedial treatments;
6. 2 or more relapses;
7. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is > 5% (by morphology), and/or > 1% (by flow cytometry);
8. Philadelphia-chromosome-negative (Ph-) patients; orPhiladelphia-chromosome-positive (Ph+) patients who cannot tolerate TKItreatments or do not respond to 2 TKI treatments;

• Inclusion criteria only for B-NHL:

1. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed fromCLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
2. Relapsed or refractory B-NHL (meeting one of the following conditions):
3. No response or relapse after second-line or above chemotherapy regimens;
4. Primary drug resistance;
5. Relapse after auto-HSCT;
6. At least one assessable tumor lesion per Lugano 2014 criteria;

• Common inclusion criteria for B-ALL and B-NHL:

1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal,creatinine ≤ 176.8 umol/L;
2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
4. Estimated survival time ≥ 3 months;
5. ECOG performance status 0 to 2;
6. Patients or their legal guardians volunteer to participate in the study and signthe informed consent.

Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascularischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tractinfectionandbacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, exceptfor the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T celltherapies;
8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients orinterfere with the results of study.