Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies

Summary

Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.

Eligibility

Inclusion Criteria:

* 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)
* Liver and kidney function, as well as cardiopulmonary function, meet requirements.
* Absolute lymphocyte count ≥ 0.5 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; CD3-positive T cells ≥ 150 cells/μL.
* Subjects must have a body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to study drug infusion and must not have significant active infection.
* Within 5 days prior to the study drug infusion, subjects must not receive therapeutic doses of corticosteroids (\>5 mg/day of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents.

Exclusion Criteria:

* 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.)
* Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), and severe arrhythmias.
* Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver, kidney, or metabolic diseases requiring medication.
* Patients with chronic progressive neurological diseases should be excluded.
* Patients who have not recovered from acute toxic effects following prior treatment must be excluded.
* Patients with active infections requiring systemic treatment or uncontrolled infections should be excluded (patients with mild urogenital tract infections and upper respiratory tract infections may be considered for inclusion).

Conditions3

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