Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.
Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions
Expected survival time exceeds 12 weeks
ECOG performance status 0-2
Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-positive hematologic malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded.
Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded.
Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion).
Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer outside normal reference range; Hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis positive. (Patients meeting any criterion in this section must be excluded.)
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead sponsor