CAR-NK Targeted CD19 for r/r B-cell Malignancies
Adult Relapsed/Refractory B-cell Hematologic Malignancies
About this trial
This is an interventional treatment trial for Adult Relapsed/Refractory B-cell Hematologic Malignancies
Eligibility Criteria
Inclusion criteria: Age ≥ 18 years old, no gender or race; Expected survival period ≥ 3 months; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Confirmed relapsed/refractory B-cell malignancies and tumor cells expressing CD19; Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Central nervous system involved; Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; Women who are pregnant (urine/blood pregnancy test positive) or lactating; Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness; 10. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.
Sites / Locations
- The Fifth Medical Center of Chinese People's Liberation Army (PLA) General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
CD19 CAR-NK(JD010)
CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.