Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Subject must meet all the following criteria to be selected:

Willing to provide consent/assent for participation in the study by patient or his/her legal guardian;
Male or Female subjects age ≥18 and ≤55 years;
Evidence of relapsed/refractory CD19+ B cell hematological malignancies. The most common relapsed/refractory B cell hematological malignancies include: (1) B cell acute lymphoblastic leukemia (B-ALL); (2) B cell lymphomas, including indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL) and aggressive B cell lymphoma (DLBCL, BL, MCL)；

Subjects (20 subjects of B cell acute lymphoblastic leukemia and 20 subjects of B cell lymphoma) with the following conditions:

Failure to achieve complete remission (CR) after at least two lines of standard chemotherapy while not suitable for HSCT (auto/allo-HSCT)；
Relapse after CR, but not eligible for HSCT (auto/allo-HSCT);
Failure to achieve remission or relapse after HSCT;
Leukemia patient confirmed by bone marrow aspiration that has not been alleviated; lymphoma patient with measurable or assessable lesions;

Adequate organ function:

Liver: ALT/AST ≥ 3 × ULN, total bilirubin ≤34.2 mol/L;
Kidney: Creatinine<220 µmol/L, creatinine clearance rate (CCR) ≥ 60 mL/min;
Lung: arterial oxygen saturation ≥95%;
Heart: Left ventricular ejection fraction (LVEF) ≥40%;
Absolute lymphocyte count (ALC) ≥ 100/μL, absolute neutrophil count (ANC) ≥ 1,000/μL, platelets (PLT) ≥ 75,000/μL;
No prior anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immunosuppression) within 4 weeks prior to enrollment, and toxic reactions of all prior treatments recovered to grade ≤1 at the time of enrollment (except for low toxicity such as alopecia);
Presence of smooth peripheral superficial venous blood flow to fulfill intravenous infusion;
Karnofsky performance score ≥60; ECOG ≤2; estimated survival ≥3 months.

Exclusion Criteria:

Subjects meeting one or more of the following criteria will be excluded:

Female patient who is pregnant or breastfeeding ;
Male or Female patient within Pregnancy Program in 1 year;
Unwilling or unable to guarantee effective contraceptive measures (condoms or contraceptives) within 1 year after enrollment;
Presence of uncontrolled infectious disease within 4 weeks prior to enrollment:
Active hepatitis B or hepatitis C infection;
HIV infection;
Active TB;
Presence of active malignancy other than disease under study, confirmed by pathology;
Severe autoimmune diseases or immunodeficiency;
Suffering from allergies;
Joining another clinical trial within 6 weeks prior to enrollment;
Using systemic corticosteroid within 4 weeks prior to enrollment (except for those who use inhaled steroids);
Psychiatric disorders;
History of epilepsy and seizures or other CNS pathology;
Addiction to or abuse of drugs;
Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol.