Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies

Korábbi kezelés

• 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 GVHD requiring immunosuppressive therapy occurred within 2 weeks before screening;
• 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;
• 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;

Más betegség

• There are uncontrollable infections;
• Conditions that other researchers deemed inappropriate for participating in the study.

Egyéb

• Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;

• 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;
• 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.