A Study of Universal CD19-Targeted UCAR-NK Cells Combined With HSCT for B Cell Hematologic Malignancies

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 universal CAR-NK(UCAR-NK) cells therapy combined with HSCT for B cell hematologic malignancies.

Inclusion Criteria:Patients with indications for hematopoietic stem cell transplantation;Age ≤75 years old;Confirmed B-cell tumor and tumor cells expressing CD19；Expected survival time >12 weeks;Eastern cooperative oncology group (ECOG) score is 0-2;Adequate liver , kidney and cardiopulmonary function;Willingness to complete the informed consent process and to comply with study procedures and visit schedule.Exclusion Criteria:Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher graft versus host disease(GVHD) requiring immunosuppressive therapy occurred within 2 weeks before screening;Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;Have received live attenuated vaccine within 6 weeks before rinsing;Had a cerebrovascular accident or seizure within 6 months before screening;History of deep venous thrombosis or pulmonary embolism within 6 months before screening;A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;Previous history of Alzheimer's disease;Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening;There are uncontrollable infections;Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion;Conditions that other researchers deemed inappropriate for participating in the study.